267 results
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19ms
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Sources: EU EUDAMED, US FDA
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Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TAVR PACK, Model Number DYNJ68499B; f) VEIN CLINIC, Model Number DYNJ68667; g) VASCULAR PACK, Model Number DYNJ68863; h) VASCULAR PACK, Model Number DYNJ68880; i) TAVR PACK, Model Number DYNJ68933; j) PROCEDURE PACK, Model Number DYNJ68968A; k) PORT PACK, Model Number DYNJ68990A; l) STROKE PACK, Model Number DYNJ69009A; m) ENDOVENOUS BASIC PACK, Model Number DYNJ69108A; n) VEIN ABLATION KIT, Model Number DYNJ69272A; o) UPPER ENDOVASCULAR PK, Model Number DYNJ69302; p) STROKE PACK, Model Number DYNJ69422; q) UNM PREHOSPITAL ECMO PACK, Model Number DYNJ69622; r) UNM ACCESS PACK, Model Number DYNJ69624; s) FLUSHING VASCULAR CENTER, Model Number DYNJ69626; t) AFIB PACK, Model Number DYNJ69682; u) ENDOVASCULAR PACK, Model Number DYNJ69691A; v) FISTULA SAVANNAH PACK, Model Number DYNJ69943A; w) VEIN PACK, Model Number DYNJ80199A; x) VEIN PACK, Model Number DYNJ80199B; y) VASCULAR PACK, Model Number DYNJ80310; z) CAROTID PACK, Model Number DYNJ80346A; aa) ENDOVENOUS ABLATION PACK, Model Number DYNJ80489; bb) STROKE KIT, Model Number DYNJ80506; cc) VEIN PACK, Model Number DYNJ80868; dd) VASCULAR ACCESS PACK, Model Number DYNJ81022; ee) VASCULAR GENERAL PACK, Model Number DYNJ81023; ff) AV FISTULA PACK, Model Number DYNJ81033; gg) TAVR PACK, Model Number DYNJ81095; hh) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200; ii) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200A; jj) LINQ PACK, Model Number DYNJ81320; kk) EP DRAPE, Model Number DYNJ81462A; ll) OR VASCULAR ANGIO PACK, Model Number DYNJ81592A; mm) OR VASCULAR ANGIO PACK, Model Number DYNJ81592B; nn) AV FISTULA PACK, Model Number DYNJ81605; oo) MAJOR VASCULAR PACK, Model Number DYNJ81610; pp) MAJOR VASCULAR PACK, Model Number DYNJ81610A; qq) MAJOR VASCULAR PACK, Model Number DYNJ81610B; rr) PROCEDURE PACK, Model Number DYNJ81618; ss) VASCULAR PACK, Model Number DYNJ81626; tt) VASCULAR PACK, Model Number DYNJ81626A; uu) VASCULAR KIT, Model Number DYNJ81642; vv) VASCULAR KIT, Model Number DYNJ81642A; ww) USGS PACK, Model Number DYNJ81705; xx) EP PACK, Model Number DYNJ81716; yy) EP PACK, Model Number DYNJ81716A; zz) EP PACK, Model Number DYNJ81716B; aaa) VASCULAR PACK, Model Number DYNJ82104; bbb) VASCULAR AND INTERVENTION, Model Number DYNJ82109; ccc) VASCULAR PACK, Model Number DYNJ82144; ddd) SPECIALS MINOR RADIOLOGY PACK, Model Number DYNJ82314; eee) TAVR PACK, Model Number DYNJ82372; fff) FISTULA PACK, Model Number DYNJ82711; ggg) IR ANGIOGRAM LIGHT PK, Model Number DYNJ82858A; hhh) IR ANGIOGRAM PACK, Model Number DYNJ82859A; iii) MARGIN SIMPLE VEIN PACK, Model Number DYNJ82987; jjj) MARGIN FULL VEIN PACK, Model Number DYNJ82988; kkk) MARGIN FULL VEIN PACK, Model Number DYNJ82988A; lll) ARTERIOGRAM PACK 2, Model Number DYNJ83051; mmm) VASCULAR PACK, Model Number DYNJ83146; nnn) VEIN PACK, Model Number DYNJ83147; ooo) ENDOVASCULAR PACK, Model Number DYNJ83161; ppp) CVOR ANGIOGRAPHY PACK, Model Number DYNJ83432; qqq) VIRC STROKE PACK, Model Number DYNJ83461; rrr) RADIO VEIN ABLATION PACK, Model Number DYNJ83490; sss) ENDOVENOUS PACK, Model Number DYNJ83606; ttt) ENDO VASCULAR PACK, Model Number DYNJ83624; uuu) ENDOVASCULAR PACK, Model Number DYNJ83972; vvv) TEMP PERM KIT, Model Number DYNJ84130; www) VASCULAR PACK, Model Number DYNJ84252; xxx) OPEN HEART PART 2, Model Number DYNJ901075O; yyy) OPEN HEART PART 2, Model Number DYNJ901075P; zzz) CAROTID-LF, Model Number DYNJ901745K; aaaa) VASCULAR ANGIO, Model Number DYNJ902259B; bbbb) VASCULAR CUT DOWN, Model Number DYNJ902261G; cccc) VASCULAR, Model Number DYNJ902704P; dddd) ENDOVASCULAR, Model Number DYNJ903451D; eeee) TICKER FIXER2, Model Number DYNJ903919J; ffff) TICK
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Model Number DYNJ0407399P; l) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA; m) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K; n) CARDIAC EP PACK-LF, Model Number DYNJ0429185L; o) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C; p) LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG; q) CATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA; r) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R; s) CARDIAC CATH PACK-LF, Model Number DYNJ0842644F; t) PEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K; u) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V; v) CARDIAC CATH PACK-LF, Model Number DYNJ0855138P; w) CARDIAC CATH PACK-LF, Model Number DYNJ0855138Q; x) IR PICC PACK-LF, Model Number DYNJ0950839C; y) SPECIAL PROCEDURES, Model Number DYNJ23288C; z) ANGIO TRAY, Model Number DYNJ23438M; aa) ADULT CARDIAC CATH PACK, Model Number DYNJ23455K; bb) ADULT CARDIAC CATH PACK, Model Number DYNJ23455L; cc) ADULT CARDIAC CATH PACK, Model Number DYNJ23455M; dd) ADULT CARDIAC CATH PACK, Model Number DYNJ23455N; ee) STENT PACK-LF, Model Number DYNJ27613K; ff) CATH I W/ ANGIO DRAPE, Model Number DYNJ33709F; gg) JUGULAR PACK, Model Number DYNJ35164C; hh) ANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F; ii) ANGIO DRAPE II-LF, Model Number DYNJ35994C; jj) ANGIO/PICC PACK, Model Number DYNJ36049A; kk) ISSAQUA CATH/IR PACK, Model Number DYNJ36738G; ll) IR PACK, Model Number DYNJ36752B; mm) ARTERIOGRAM TRAY-LF, Model Number DYNJ36807C; nn) SPECIAL PROCEDURE PACK, Model Number DYNJ38314G; oo) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G; pp) CARDIAC CATH PACK, Model Number DYNJ38866F; qq) INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B; rr) ABLATION PACK, Model Number DYNJ40629C; ss) CATH LAB PACK, Model Number DYNJ40926A; tt) RADIOLOGY PACK, Model Number DYNJ41190; uu) TV IR PACK-LF, Model Number DYNJ41562F; vv) CUSTOM ANGIO TRAY, Model Number DYNJ41649G; ww) CARDIAC CATH DRAPE PACK, Model Number DYNJ41700A; xx) IR PACK, Model Number DYNJ41989G; yy) INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C; zz) ANGIO PACK, Model Number DYNJ42903C; aaa) ANGIO PACK, Model Number DYNJ42903D; bbb) CARDIAC CATH PACK-LF, Model Number DYNJ42996C; ccc) DIALYSIS TRAY, Model Number DYNJ43060B; ddd) ANGIOPLASTY PACK-LF, Model Number DYNJ43203G; eee) ARTERIOGRAM PACK, Model Number DYNJ43261J; fff) CATH LAB RIGHT HEART PACK, Model Number DYNJ43315L; ggg) ANGIO CATH COMBINED PACK, Model Number DYNJ43609P; hhh) ANGIO CATH COMBINED PACK, Model Number DYNJ43609R; iii) ANGIO CATH COMBINED PACK, Model Number DYNJ43609S; jjj) ANGIO PACK, Model Number DYNJ43661C; kkk) ABLATION EP PACK, Model Number DYNJ43851B; lll) PK, RADIOLOGY, Model Number DYNJ43894B; mmm) PK, RADIOLOGY, Model Number DYNJ44087A; nnn) ANGIOGRAPHY PACK, Model Number DYNJ44293F; ooo) ANGIO DRAPE PACK, Model Number DYNJ44320G; ppp) ANGIO DRAPE PACK, Model Number DYNJ44320I; qqq) ANGIO DRAPE PACK, Model Number DYNJ44320J; rrr) FEMORAL ANGIO PACK, Model Number DYNJ44334M; sss) FEMORAL ANGIO PACK, Model Number DYNJ44334N; ttt) RADIOLOGY PACK, Model Number DYNJ44524F; uuu) ANGIO PACK, Model Number DYNJ44642B; vvv) ANGIOPLASTY PACK, Model Number DYNJ44700J; www) ANGIO PACK, Model Number DYNJ44993J; xxx) ANGIOGRAPHY PACK, Model Number DYNJ45059B; yyy) PERCUTANEOUS PACK, Model Number D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F; e) CHP TRANSPLANT CDS, Model Number CDS983082J; f) CLOSURE CDS, Model Number CDS983704I; g) MIDLINE INSERTION TRAY, Model Number CVI4340; h) PORT INSERTION PACK, Model Number CVI4765; i) MAX BARRIER KIT, Model Number DYND2673B; j) POWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C; k) DEPIPPO PACK, Model Number DYNDA2011B; l) VEIN PROCEDURE KIT, Model Number DYNDA2076; m) SCLEROTHERAPY KIT, Model Number DYNDA2148A; n) IR SONO PACK, Model Number DYNDA2365B; o) ULTRASOUND BASIC KIT, Model Number DYNDC2099; p) PIV WITH ULTRASOUND KIT, Model Number DYNDC2399A; q) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; r) ULTRASOUND TRAY, Model Number DYNDH1204; s) PARA/THORACENTESIS TRAY, Model Number DYNDH1292; t) ULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319; u) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; v) PARA/THORACENTESIS TRAY, Model Number DYNDH1470C; w) US GUIDED LOC KIT, Model Number DYNDH1492; x) AMINO KIT, Model Number DYNDH1649; y) BREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A; z) ULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B; aa) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A; bb) CVL PACK, Model Number DYNJ00281N; cc) FEM POP PACK, Model Number DYNJ01964M; dd) MAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D; ee) VEIN PACK, Model Number DYNJ0309084D; ff) DR. BAHDOUCH PACK, Model Number DYNJ0351069; gg) ANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q; hh) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y; ii) JUDKINS PACK-LF, Model Number DYNJ0530948AR; jj) JUDKINS PACK-LF, Model Number DYNJ0586030P; kk) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q; ll) MINI PACK-LF, Model Number DYNJ0604540P; mm) MINI PACK-LF, Model Number DYNJ0604540Q; nn) BIOPSY PACK-LF, Model Number DYNJ0747885F; oo) PERC PACK-LF, Model Number DYNJ0774759O; pp) PERC PACK-LF, Model Number DYNJ0774759P; qq) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821N; rr) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821O; ss) CLOSURE PACK-LF, Model Number DYNJ0807503M; tt) LINE PLACEMENT PACK-LF, Model Number DYNJ0931376F; uu) DENTAL PACK-LF, Model Number DYNJ0952428; vv) VENOUS ACCESS TRAY, Model Number DYNJ20094K; ww) DEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D; xx) VEIN CLOSURE PACK, Model Number DYNJ32397B; yy) LARGE PROCEDURE PACK, Model Number DYNJ35524D; zz) RAD CVC TRAY, Model Number DYNJ35574A; aaa) WILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J; bbb) WILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G; ccc) STERILE PICC TRAY-LF, Model Number DYNJ36814B; ddd) PARA/THORA PACK, Model Number DYNJ37280C; eee) BASIC PACK, Model Number DYNJ37460A; fff) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F; ggg) MINOR PROCEDURE PACK, Model Number DYNJ38563O; hhh) VEIN PACK, Model Number DYNJ38682C; iii) ADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B; jjj) PICC LINE INSERTION, Model Number DYNJ39885A; kkk) PEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A; lll) HL VEIN STRIPPING PACK, Model Number DYNJ40374A; mmm) GENERAL USE PACK, Model Number DYNJ41137B; nnn) PICC LINE INSERTION WRO-LF, Model Number DYNJ41873B; ooo) CV ACCESS PACK WRO-LF, Model Number DYNJ41875B; ppp) RADIOLOGY PACK, Model Number DYNJ42172A; qqq) BASIC PACK, Model Number DYNJ42691; rrr) DRAINAGE TRAY, Model Number DYNJ42913; sss) DRAINAGE TRAY, Model Number DYNJ42913A; ttt) IR MINI KIT, Model Number DYNJ44519F; uuu) IR PERIPHERAL PACK, Model Number DYNJ45033A; vvv) EVLT CORE PACK, Model Number DYNJ45294; www) EVLT PACK, Model Number DYNJ45997C; xxx) PHLEBECTOMY PACK, Model Number DYNJ47502B; yyy) LINE KIT, Model Number DYNJ47987B; zzz) VEI
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B; j) RFA PACK, Model Number DYNJ57149; k) SPECIALS TRACE PACK, Model Number DYNJ57303B; l) CLOSURE PACK, Model Number DYNJ57514; m) EP PACK, Model Number DYNJ57594A; n) VEIN TRAY, Model Number DYNJ57736A; o) ENSEMBLE PICC LINE-LF, Model Number DYNJ57793; p) PICC LINE PACK-LF, Model Number DYNJ58160; q) ENDOVENOUS PACK, Model Number DYNJ58228; r) BIB AV FISTULA PACK, Model Number DYNJ58304; s) TRIPLE P KIT, Model Number DYNJ58424; t) LINQ TRAY, Model Number DYNJ58643A; u) TUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062; v) PICC PROCEDURE PACK, Model Number DYNJ59067; w) ENDOVASCULAR PACK, Model Number DYNJ59085; x) VEIN CLOSURE PACK, Model Number DYNJ59094; y) CLOSURE PROCEDURE, Model Number DYNJ59206; z) VNUS PACK, Model Number DYNJ59246; aa) DESERT CARDIOVASCULAR PACK, Model Number DYNJ59377; bb) EP LAB, Model Number DYNJ59392C; cc) VEIN PACK-LF, Model Number DYNJ59631; dd) PROCEDURE PACK, Model Number DYNJ59795A; ee) PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126A; ff) KF PACK, Model Number DYNJ60127A; gg) VENASEAL PACK, Model Number DYNJ60128A; hh) I.R. PACK, Model Number DYNJ60343A; ii) CLOSURE PACK, Model Number DYNJ60804; jj) CLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067; kk) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A; ll) ECMO PACK, Model Number DYNJ61243; mm) VEIN PACK, Model Number DYNJ61264; nn) UNIVERSAL PACK, Model Number DYNJ61433; oo) OCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517; pp) ENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295; qq) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295A; rr) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B; ss) SCLEROTHERAPY KIT, Model Number DYNJ62434A; tt) ABLATION PACK, Model Number DYNJ62540; uu) PROCEDURE PACK, Model Number DYNJ62588; vv) VEIN ABLATION, Model Number DYNJ63268B; ww) TF TAVR PACK, Model Number DYNJ63340; xx) AFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C; yy) ALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A; zz) NIR PACK, Model Number DYNJ63892; aaa) ABLATION PACK, Model Number DYNJ64068; bbb) LASER KIT, Model Number DYNJ64075A; ccc) EVLT, Model Number DYNJ64336; ddd) PROCEDURE PACK, Model Number DYNJ64372A; eee) PREMIER PROCEDURE PACK, Model Number DYNJ64393; fff) MINOR SET UP PACK, Model Number DYNJ64439; ggg) VIP PACK, Model Number DYNJ64666A; hhh) CT ABLATION PACK, Model Number DYNJ64928A; iii) ULTRASOUND KIT, Model Number DYNJ64930; jjj) VEIN CLOSURE PACK, Model Number DYNJ65189C; kkk) PACK,LTD BODY SSP, Model Number DYNJ65488B; lll) EVLT PACK, Model Number DYNJ65995; mmm) EVLT PACK, Model Number DYNJ65995A; nnn) EVLT PACK, Model Number DYNJ66005; ooo) JVL-PACK TUNNELED, Model Number DYNJ66065; ppp) EVLA PACK, Model Number DYNJ66258; qqq) EVLA PACK, Model Number DYNJ66258A; rrr) ANGIOGRAM SET UP PACK, Model Number DYNJ66260; sss) IR PACKER, Model Number DYNJ66620A; ttt) CLOSURE PROCEDURE PACK, Model Number DYNJ66741; uuu) PHYSIATRY PACK, Model Number DYNJ67414; vvv) FEM POP PACK, Model Number DYNJ67487A; www) SPECIALS PACK, Model Number DYNJ67504A; xxx) SPECIALS PACK, Model Number DYNJ67504B; yyy) RFA PACK, Model Number DYNJ67899; zzz) RR-BRACHY PACK, Model Number DYNJ68027; aaaa) COPS PROCEDURE PACK-LF, Model Number DYNJ68923A; bbbb) PROCEDURE PACK, Model Number DYNJ68968; cccc) PORT PACK, Model Number DYNJ68990; dddd) ACCESS PACK, Model Number DYNJ69017; eeee) KF PACK 2.0, Model Number DYNJ69619; ffff) NLK BASIC PACK, Model Number DYNJ69716A; gg
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA2482; i) ULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669; j) I.R. PICC PACK, Model Number DYNDA2759; k) IR SONO PACK, Model Number DYNDA3010; l) NEONATAL PICC LINE TRAY, Model Number DYNDC2120B; m) PICC SUPPLEMENTAL KIT, Model Number DYNDC2373A; n) CENTRAL LINE KIT, Model Number DYNDC2582A; o) CENTRAL LINE KIT UTMB, Model Number DYNDC3061; p) FNA TRAY, Model Number DYNDH1123B; q) CVL PACK, Model Number DYNJ00281O; r) CENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O; s) CENTRAL LINE PACK-LF, Model Number DYNJ0220136Q; t) PICC LINE PACK-LF, Model Number DYNJ0235859I; u) PICC LINE PACK-LF, Model Number DYNJ0235859J; v) PICC LINE PACK-LF, Model Number DYNJ0235859K; w) PICC LINE PACK, Model Number DYNJ04592K; x) PICC LINE PACK-LF, Model Number DYNJ0678523N; y) PICC LINE PACK-LF, Model Number DYNJ0855123N; z) PICC INSERTION PACK-LF, Model Number DYNJ0880659F; aa) PICC PACK-LF, Model Number DYNJ0940720D; bb) VENOUS ACCESS PACK-LF, Model Number DYNJ09895R; cc) PICC PACK-LF, Model Number DYNJ17086A; dd) VENOUS ACCESS TRAY, Model Number DYNJ20094L; ee) PICC LINE PACK-LF, Model Number DYNJ21575I; ff) CENTRAL LINE PACK, Model Number DYNJ30087C; gg) PICC LINE PACK, Model Number DYNJ30233C; hh) PICC PACK, Model Number DYNJ30566B; ii) CENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G; jj) PICC TRAY, Model Number DYNJ33005F; kk) PICC TRAY, Model Number DYNJ33005G; ll) PICC LINE INSERTION TRAY, Model Number DYNJ34241; mm) PICC PACK-LF, Model Number DYNJ35000I; nn) PORT PACK, Model Number DYNJ35163C; oo) PICC TRAY-LF, Model Number DYNJ35272; pp) PICC LINE INSERTION PACK, Model Number DYNJ38868K; qq) PICC LINE INSERTION PACK, Model Number DYNJ38868L; rr) PICC ACCESSORY TRAY, Model Number DYNJ39039M; ss) CVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B; tt) PICC INSERTION PACK MH-LF, Model Number DYNJ40206B; uu) ACCESS PICC PACK, Model Number DYNJ40682B; vv) PHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C; ww) MV-IR-PICC PACK-LF, Model Number DYNJ41554C; xx) PICC TRAY, Model Number DYNJ41648; yy) CENTRAL LINE TRAY, Model Number DYNJ42902C; zz) CENTRAL LINE TRAY, Model Number DYNJ42902D; aaa) VENOUS PACK, Model Number DYNJ43168; bbb) VENOUS PACK, Model Number DYNJ43168A; ccc) VENOUS PACK, Model Number DYNJ43168B; ddd) IR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G; eee) WEST VALLEY PICC LINE PACK, Model Number DYNJ43975A; fff) VENOUS LIGATION PACK, Model Number DYNJ43981G; ggg) VEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C; hhh) VENOUS ABLATION, Model Number DYNJ44904C; iii) PICC LINE PACK, Model Number DYNJ47037C; jjj) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B; kkk) CENTRAL LINE PACK, Model Number DYNJ48096B; lll) PICC PACK-LF, Model Number DYNJ48120B; mmm) AV FISTULA PACK-LF, Model Number DYNJ48428C; nnn) VIEN CLOSURE, Model Number DYNJ49180A; ooo) ARTERIAL LINE PACK, Model Number DYNJ49235D; ppp) PICC PACK, Model Number DYNJ52255; qqq) PICC LINE TRAY, Model Number DYNJ52688B; rrr) PICC LINE TRAY, Model Number DYNJ52688C; sss) CENTRAL LINE INSERTION KIT, Model Number DYNJ52894A; ttt) ARTERIOGRAM PACK, Model Number DYNJ53095A; uuu) ENDOVENOUS ABLATION PACK, Model Number DYNJ53435D; vvv) MID HUDSON PICC LINE PACK, Model Number DYNJ53618A; www) MSB BEDSIDE TRAY, Model Number DYNJ54670; xxx) LEE VEIN PACK, Model Number DYNJ54906C; yyy) ARTERIOGRAM PACK, Model Number DYNJ55169G; zzz) PICC LINE PACK, Model Number DYNJ55170B; aaaa) PICC LINE PACK, M
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Model Number DYNJ56547C; f) HYBRID, Model Number DYNJ57049G; g) HYBRID, Model Number DYNJ57049I; h) HYBRID, Model Number DYNJ57049J; i) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C; j) GENERAL ANGIO PACK, Model Number DYNJ57760C; k) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C; l) ANGIO PACK, Model Number DYNJ58111D; m) ANGIO PACK, Model Number DYNJ58111F; n) PORT PACK, Model Number DYNJ58162; o) ENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B; p) PERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A; q) OR ANGIO PACK, Model Number DYNJ59184B; r) PORT A CATH PACK, Model Number DYNJ59307F; s) CATH PACK, Model Number DYNJ59632D; t) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112B; u) I.R. PACK, Model Number DYNJ60343B; v) I.R. PACK, Model Number DYNJ60343C; w) CATH LAB PACK, Model Number DYNJ60763; x) CRMC ANGIOGRAM-LF, Model Number DYNJ61082C; y) CRMC ANGIOGRAM-LF, Model Number DYNJ61082D; z) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B; aa) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C; bb) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C; cc) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D; dd) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F; ee) MAIN OR CATH LAB, Model Number DYNJ61373A; ff) CARDIAC CATH PACK-LF, Model Number DYNJ61527A; gg) IR PACK, Model Number DYNJ61646A; hh) PERMA CATH PACK, Model Number DYNJ62007A; ii) IR PACK, Model Number DYNJ62037D; jj) AV FISTULA PACK, Model Number DYNJ62733A; kk) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B; ll) CATH PACK, Model Number DYNJ63181A; mm) CATH PACK, Model Number DYNJ63181B; nn) CATH PACK, Model Number DYNJ63181C; oo) CATH ANGIO PACK, Model Number DYNJ64050A; pp) ANGIOPLASTY PACK-LF, Model Number DYNJ64655C; qq) IR GENERAL PACK, Model Number DYNJ64976; rr) HEART TAVR PACK, Model Number DYNJ65174D; ss) ANGIOGRAPHY PACK, Model Number DYNJ65190D; tt) ANGIOGRAPHY PACK, Model Number DYNJ65190F; uu) PACK,CARDIAC CATH, Model Number DYNJ65481; vv) RADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913; ww) CATH LAB PACK, Model Number DYNJ66166A; xx) CATH I W SPLIT DRAPE PACK, Model Number DYNJ66182; yy) PORT A CATH INSERT PK, Model Number DYNJ66257; zz) PORT A CATH INSERT PK, Model Number DYNJ66257A; aaa) PORT A CATH INSERT PK, Model Number DYNJ66257B; bbb) FISTULAGRAM PACK, Model Number DYNJ66259A; ccc) ANGIOGRAM SET UP PACK, Model Number DYNJ66260A; ddd) CATH PACK, Model Number DYNJ66473A; eee) ANGIOGRAPHY PACK, Model Number DYNJ66476A; fff) FEMORAL PACK, Model Number DYNJ66515A; ggg) IR PACK UNION, Model Number DYNJ66926A; hhh) STANDARD ANGIO TRAY MV, Model Number DYNJ67136A; iii) ANGIOGRAPHY PACK, Model Number DYNJ67144A; jjj) DRAINAGE PROCEDURE PACK, Model Number DYNJ67149A; kkk) CARDIAC CATH PACK, Model Number DYNJ67174A; lll) CARDIAC CATH PACK, Model Number DYNJ67174B; mmm) OR ANGIOGRAPHY PACK, Model Number DYNJ67245A; nnn) OR ANGIOGRAPHY PACK, Model Number DYNJ67245B; ooo) ANGIOGRAPHIC TRAY, Model Number DYNJ67320A; ppp) IR PACK, Model Number DYNJ67737; qqq) TUNNEL LINE PACK, Model Number DYNJ67990A; rrr) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B; sss) NEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B; ttt) IR PACK, Model Number DYNJ68538; uuu) SPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729; vvv) IR PACK, Model Number DYNJ68729B; www) CATH LAB ANGIO TRAY, Model Number DYNJ68763; xxx) CATH LAB ANGIO TRAY, Model Number DYNJ68763A; yyy) IR RADIOLOGY PACK, Model Number DYNJ69056; zzz) IR RADIOLOGY PACK, Model Number DYNJ69056A; aaaa) ANGIO PACK, Model Number DYNJ69200; bbbb) HGH TAVI PACK, Model Number DYNJ69298; cccc) ANGIO TRAY, Model Number DYNJ69421; dddd) ENDOV
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A; d) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A; e) CENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725; f) INTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915; g) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B; h) CVC BUNDLE KIT 20CM, Model Number ECVC2001; i) 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A; j) CVC BUNDLE KIT 16CM, Model Number ECVC2240A; k) FIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320; l) 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B; m) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555; n) 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560; o) FIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720; p) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745; q) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750; r) 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770; s) CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895; t) SHEATH INTRODUCER BUNDLE, Model Number ECVC2930; u) DUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940; v) TRIPLE LUMEN BUNDLE, Model Number ECVC2965; w) TRIPLE LUMEN BUNDLE, Model Number ECVC3155; x) CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A; y) CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286; z) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355; aa) TRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395; bb) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460; cc) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505; dd) 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545; ee) TRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A; ff) CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A; gg) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785; hh) MULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900; ii) QUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135; jj) AVA HIGH FLOW BUNDLE, Model Number ECVC4300; kk) 20CM 7F CVC INSERTION TRAY, Model Number ECVC4335; ll) OLEAN GENERAL CVC BUNDLE, Model Number ECVC4615; mm) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A; nn) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A; oo) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880; pp) DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985; qq) QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995; rr) 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A; ss) TRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015; tt) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020; uu) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A; vv) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080; ww) 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B; xx) TRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200; yy) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270; zz) CVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310; aaa) CVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315; bbb) TRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B; ccc) CVC ZONE DEFENSE BUNDLE, Model Number ECVC5385; ddd) TRIPLE LUMEN BUNDLE, Model Number ECVC5475; eee) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number ECVC5480; fff) CVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A; ggg) CNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A; hhh) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A; iii) CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A; jjj) CVC DOUBLE LUMEN 16CM, Model Number ECVC5585B; kkk) CVC TRIPLE LUMEN 16CM, Model Number ECVC5590B; lll) PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART FAILURE PK, Model Number DYNJ55528A; j) HEART FAILURE PK, Model Number DYNJ55528B; k) HEART FAILURE PK, Model Number DYNJ55528C; l) ROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C; m) OPEN HEART ANGIO PACK, Model Number DYNJ55836B; n) DR NACKMAN VEIN PACK, Model Number DYNJ56235; o) KT TAVR PACK, Model Number DYNJ56283D; p) KT TAVR PACK, Model Number DYNJ56283F; q) VEIN PACK, Model Number DYNJ56724B; r) VASCULAR PACK, Model Number DYNJ56791A; s) VASCULAR PACK, Model Number DYNJ56791B; t) ECMO PACK, Model Number DYNJ56904; u) VEIN KIT, Model Number DYNJ57047; v) EH TAVR PACK, Model Number DYNJ57449F; w) EH TAVR PACK, Model Number DYNJ57449G; x) VASCULAR PACK, Model Number DYNJ57490A; y) VEIN PACK, Model Number DYNJ57512; z) DEVICE PACK, Model Number DYNJ57595A; aa) CAROTID PACK-LF, Model Number DYNJ57646B; bb) CAROTID PACK-LF, Model Number DYNJ57646C; cc) CATH LAB PACK, Model Number DYNJ57735F; dd) VEIN PACK, Model Number DYNJ57835; ee) VEIN PACK, Model Number DYNJ57917; ff) ENS. THROMBOLYSE/EMBOLISAT-LF, Model Number DYNJ58179C; gg) HEART VALVE PACK, Model Number DYNJ58365J; hh) VEIN PACK, Model Number DYNJ58609; ii) VASCULAR PACK, Model Number DYNJ58681A; jj) VASCULAR PACK, Model Number DYNJ58681B; kk) VASCULAR PACK, Model Number DYNJ58710; ll) DR HARRISON VEIN PACK II, Model Number DYNJ59028A; mm) VEIN PACK, Model Number DYNJ59151F; nn) EP LAB, Model Number DYNJ59392D; oo) EP LAB, Model Number DYNJ59392F; pp) VEIN PACK, Model Number DYNJ59662D; qq) VEIN PACK, Model Number DYNJ59681A; rr) VASCULAR PACK CHRG, Model Number DYNJ59778B; ss) VASCULAR ACCESS KIT, Model Number DYNJ59796C; tt) CATH PACK, Model Number DYNJ59830A; uu) VENOUS ACCESS ACCESSORY PACK, Model Number DYNJ61010A; vv) DR SIRAGUSA VEIN PACK, Model Number DYNJ61247; ww) MAIN OR CATH LAB, Model Number DYNJ61373; xx) VASCULAR PACK, Model Number DYNJ61528; yy) VASCULAR PACK, Model Number DYNJ61528A; zz) VEIN PACK, Model Number DYNJ61540C; aaa) NEURO VASCULAR PACK, Model Number DYNJ61584A; bbb) ABLATION PACK, Model Number DYNJ61957A; ccc) HEART GROIN PACK, Model Number DYNJ61981C; ddd) PERMA CATH PACK, Model Number DYNJ62007B; eee) PURPLE PACK, Model Number DYNJ62197A; fff) PURPLE PACK, Model Number DYNJ62197B; ggg) CLOVIS CATH LAB PACK, Model Number DYNJ62379A; hhh) VASCULAR PACK, Model Number DYNJ62399A; iii) NORTH TEXAS VASCULAR, Model Number DYNJ62735; jjj) VEIN TRAY, Model Number DYNJ62829A; kkk) HEART VEIN NYC LASER ABLATION, Model Number DYNJ62850A; lll) HEART VEIN NYC -ARTERIAL PACK, Model Number DYNJ62851B; mmm) TAVR PACK, Model Number DYNJ62915B; nnn) PACER SET UP PACK, Model Number DYNJ63069A; ooo) OPEN HEART TAVR PACK, Model Number DYNJ63099D; ppp) OPEN HEART TAVR PACK, Model Number DYNJ63099F; qqq) ELECTROPHYSIOLOGY PACK, Model Number DYNJ63209; rrr) TAVR PACK, Model Number DYNJ63340A; sss) VEIN PACK, Model Number DYNJ63823; ttt) NIR PACK, Model Number DYNJ63892A; uuu) VEIN ABLATION TRAY W/CHLOR, Model Number DYNJ64396; vvv) TORRES-VEIN PACK, Model Number DYNJ64449; www) VEIN PACK, Model Number DYNJ64471A; xxx) CVOR ENDOVASCULAR PACK, Model Number DYNJ64506A; yyy) HEART FAILURE PACK, Model Number DYNJ64877B; zzz) CT ABLATION PACK, Model Number DYNJ64928; aaaa) VEIN PROCEDURE, Model Number DYNJ65342A; bbbb) SMALL TRAY VASCULAR PACK, Model Number DYNJ65418; cccc) VEIN OHH, Model Number DYNJ65560A; dddd) PORT PICC TUNNEL PACK, Model Number DYNJ65775A; eeee) VARITHENA PACK, Model Number DYNJ65
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983849D; i. OPEN HEART ANESTHESIA PACK, Model Number CDS983849F; j. VNUS, Model Number CDS984292I; k. OPEN HEART CDS, Model Number CDS984355G; l. BEDSIDE PICC CDS, Model Number CDS984642; m. VASCULAR, Model Number CDS984764G; n. OPEN HEART A, Model Number CDS985105O; o. VASCULAR, Model Number CDS985355D; p. VASCULAR, Model Number CDS985355F; q. ECMO KIT, Model Number CVI4955; r. KIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21; s. VASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526; t. ARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038; u. DIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B; v. OPEN HEART CABG PACK-LF, Model Number DYNJ0149567C; w. VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ; x. OPEN HEART PACK-LF, Model Number DYNJ0371669N; y. CABG PACK, Model Number DYNJ0408782AA; z. CARDIAC EP PACK-LF, Model Number DYNJ0429185K; aa. CARDIAC EP PACK-LF, Model Number DYNJ0429185M; bb. OPEN HEART A & B PACK, Model Number DYNJ0450131AI; cc. VASCULAR PACK-LF, Model Number DYNJ0493141J; dd. RIGHT HEART PACK-LF, Model Number DYNJ0565558U; ee. ENDO VASCULAR PACK-LF, Model Number DYNJ0676055N; ff. LOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G; gg. ENDOVASCULAR PACK, Model Number DYNJ0678934I; hh. RR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J; ii. ELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D; jj. VASCULAR PACK-LF, Model Number DYNJ0871182AC; kk. ELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D; ll. EP PACK, Model Number DYNJ16618J; mm. EP PACK, Model Number DYNJ16618K; nn. ST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C; oo. VEIN PACK, Model Number DYNJ21949J; pp. VASCULAR PACK, Model Number DYNJ22350L; qq. EP PACK, Model Number DYNJ23456K; rr. ANGIO-VASCULAR, Model Number DYNJ24272C; ss. EP ANGIO PACK, Model Number DYNJ25749S; tt. C.V. MINOR PACK, Model Number DYNJ28849B; uu. EP TRAY, Model Number DYNJ31928D; vv. PACER PACK, Model Number DYNJ34844C; ww. ADULT CARDIO TRAY, Model Number DYNJ35495G; xx. PEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G; yy. CARDIO B PACK, Model Number DYNJ36052O; zz. VASCULAR ENDO LASER PK, Model Number DYNJ37445I; aaa. VEIN PROCEDURE PACK, Model Number DYNJ38264D; bbb. HMT VEIN PACK, Model Number DYNJ38756B; ccc. LASER AND VEIN PACK, Model Number DYNJ38995C; ddd. VEIN CLOSURE PACK, Model Number DYNJ39408F; eee. CAROTID PACK, Model Number DYNJ39488G; fff. VEIN PACK, Model Number DYNJ39889; ggg. CVL CUSTOM PACK, Model Number DYNJ40067G; hhh. AV GRAFT-LF, Model Number DYNJ40077F; iii. VASCULAR-LF, Model Number DYNJ40108I; jjj. INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C; kkk. RIGHT HEART TRAY, Model Number DYNJ40379D; lll. LINE PACK, Model Number DYNJ41100C; mmm. CARDIAC CATH PACK, Model Number DYNJ41195D; nnn. VEIN PK, Model Number DYNJ42976; ooo. VEIN CLOSURE PACK, Model Number DYNJ43085A; ppp. PROCEDURE PACK, Model Number DYNJ43922; qqq. PK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B; rrr. PACEMAKER PACK, Model Number DYNJ44345F; sss. PACEMAKER PACK, Model Number DYNJ44345G; ttt. VENOUS ACCESS PACK, Model Number DYNJ44421D; uuu. VEIN CLOSURE TRAY, Model Number DYNJ44737B; vvv. ENDO LASER ABLATION PK-LF, Model Number DYNJ44808G; www. PK, OPEN HEART, Model Number DYNJ45074C; xxx. VASCULAR PACK, Model Number DYNJ46246A; yyy. CVP PACK, Model Number DYNJ46359D; zzz. INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B; aaaa. EP DRAPE PACK-LF, Model Number DYNJ47645C; bbbb. RF OPEN HEAR
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827; f) PICC PACK, Model Number DYNJ65838; g) JVL-PACK PICC, Model Number DYNJ66062; h) FISTULAGRAM PACK, Model Number DYNJ66259; i) VEIN PACK-LF, Model Number DYNJ66271B; j) VEIN PACK-LF, Model Number DYNJ66271D; k) VASCULAR PACK, Model Number DYNJ66356F; l) VENOUS PACK, Model Number DYNJ66499A; m) VENOUS PACK, Model Number DYNJ66499B; n) VEIN PACK, Model Number DYNJ66743B; o) AV FISTULA PACK, Model Number DYNJ66916; p) VEIN ABLATION PLUS W CHL, Model Number DYNJ67115A; q) PICC INSERTION TRAY, Model Number DYNJ67415; r) AFCH CVC INSERTION, Model Number DYNJ67534; s) ENS PICC LINE-HEJ-LF, Model Number DYNJ67606; t) VEIN TRAY, Model Number DYNJ69012A; u) PICC PACK, Model Number DYNJ69088; v) PICC PACK, Model Number DYNJ69088A; w) VEIN PACK, Model Number DYNJ69091A; x) VEIN PACK, Model Number DYNJ69091B; y) VEIN PACK, Model Number DYNJ69177; z) VEIN ABLATION KIT, Model Number DYNJ69272; aa) VEIN ABLATION PACK, Model Number DYNJ69288; bb) BASIC VEIN PACK, Model Number DYNJ69426; cc) VASCULAR VEIN PACK, Model Number DYNJ69769; dd) BCH VEIN ABLATION, Model Number DYNJ69796; ee) VEIN PACK, Model Number DYNJ69942A; ff) FISTULA SAVANNAH PACK, Model Number DYNJ69943; gg) VEIN CLOSURE PACK, Model Number DYNJ69976; hh) VEIN CLOSURE PACK, Model Number DYNJ69976A; ii) VENCLOSE PROCEDURE PACK, Model Number DYNJ80123; jj) VENOUS PACK, Model Number DYNJ80169; kk) VENOUS PACK, Model Number DYNJ80169A; ll) CVR ENDOVENOUS PACK, Model Number DYNJ80643; mm) VENOUS PACK, Model Number DYNJ80692; nn) VENOUS PACK, Model Number DYNJ80692A; oo) VEIN PACK, Model Number DYNJ81120; pp) VEIN PROCEDURE PACK, Model Number DYNJ81177; qq) VEIN PACK, Model Number DYNJ81212A; rr) SUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267; ss) OR VASCULAR ANGIO PACK, Model Number DYNJ81592; tt) PARAGON VEIN PACK, Model Number DYNJ81669; uu) PARAGON VEIN PACK, Model Number DYNJ81669B; vv) ANGIOGRAM-DECH-LF, Model Number DYNJ81725; ww) PICC-DECH-LF, Model Number DYNJ81726; xx) VEIN CLOSURE PACK, Model Number DYNJ81834; yy) VEIN PACK, Model Number DYNJ82033; zz) VEIN PACK, Model Number DYNJ82033A; aaa) SUPERFICIAL VENOUS PACK, Model Number DYNJ82100; bbb) SUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101; ccc) VEIN PROCEDURE TRAY, Model Number DYNJ82581; ddd) VARICOSE VEIN PACK, Model Number DYNJ82884; eee) VARICOSE VEIN PACK, Model Number DYNJ82885; fff) LASER VEIN EC PACK, Model Number DYNJ82951; ggg) SUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989; hhh) PORT DIALYSIS PACK, Model Number DYNJ83087; iii) DEXMED ACCESS PACK, Model Number DYNJ83148; jjj) VEIN TRAY, Model Number DYNJ83384A; kkk) RADIO VEIN ABLATION PACK, Model Number DYNJ83534; lll) VEIN PACK, Model Number DYNJ83747; mmm) VEIN ABLATION PACK, Model Number DYNJ83846; nnn) VEIN PACK, Model Number DYNJ83914; ooo) VEIN PACK, Model Number DYNJ83935; ppp) VEIN ABLATION PACK, Model Number DYNJ83974; qqq) VENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I; rrr) VASCULAR ACCESS-LF, Model Number DYNJ905285D; sss) GENERAL AV FISTULA, Model Number DYNJ906011B; ttt) KIT VEIN ABLATION, Model Number DYNJ907381; uuu) OPEN VASCULAR UE, Model Number DYNJ907858; vvv) PICC LINE TRAY-LF, Model Number DYNJT2272J; www) PICC LINE TRAY-LF, Model Number DYNJT2272K; xxx) PICC CUSTOM PACK, Model Number GSS584Q; yyy) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A; zzz) PEDS/ NICU LINE KIT, Model Number MNS13555; aaaa) ER CENTRAL LINE KIT, Model Number P155508D; bbbb) PICC INSERTION TRAY, Model Number PICC0018; cccc) PICC TRAY, Model Number PICCNC0008; dddd) PQ PICC LINE PACK, Model Number PICCNC0013; eeee) STANDARD PICC II-LF, Model Number
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609; 6) STERILE ANGIOGRAPHY PACK, Catalog Number SAN13BS60K; 7) ANGIOGRAPHY PACK, Catalog Number SAN13BS60L; 8) ANGIOGRAPHY PACK, Catalog Number SAN13BS60M; 9) ANGIOGRAPHY PACK, Catalog Number SAN13BS60N; 10) ANGIOGRAPHY PACK, Catalog Number SAN13BS60O; 11) CATH LAB PACK, Catalog Number SAN13CLET2; 12) CATH LAB PACK, Catalog Number SAN13CLETC; 13) CATH LAB PACK, Catalog Number SAN13CLETD; 14) ARTERIOGRAM PACK, Catalog Number SAN21AGE10; 15) ARTERIOGRAM PACK, Catalog Number SAN21AGEG6; 16) ARTERIOGRAM PACK, Catalog Number SAN21AGEG7; 17) ARTERIOGRAM PACK, Catalog Number SAN21AGEG8; 18) ARTERIOGRAM PACK, Catalog Number SAN21AGEG9; 19) ARTERIOGRAM PACK, Catalog Number SAN21AGEGJ; 20) ARTERIOGRAM PACK, Catalog Number SAN21AGEGK; 21) ARTERIOGRAM PACK, Catalog Number SAN21AGEGL; 22) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ10; 23) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ11; 24) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ12; 25) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ13; 26) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ14; 27) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ15; 28) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ16; 29) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ17; 30) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ18; 31) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ19; 32) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC6; 33) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC7; 34) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC8; 35) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC9; 36) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJCH; 37) CVL PACK, Catalog Number SAN22CVW12; 38) CVL PACK, Catalog Number SAN22CVW14; 39) CVL PACK, Catalog Number SAN22CVW15; 40) CVL PACK, Catalog Number SAN22CVW16; 41) CVL PACK, Catalog Number SAN22CVW17; 42) CVL PACK, Catalog Number SAN22CVW18; 43) CVL PACK, Catalog Number SAN22CVW19; 44) CVL PACK, Catalog Number SAN22CVW20; 45) CVL PACK, Catalog Number SAN22CVWRK; 46) CVL PACK, Catalog Number SAN22CVWRL; 47) ACCESSORY PACK, Catalog Number SAN37ASMO3; 48) ACCESSORY PACK, Catalog Number SAN37ASMO4; 49) ACCESSORY PACK, Catalog Number SAN37ASMO5; 50) ACCESSORY PACK, Catalog Number SAN37ASMOE; 51) ACCESSORY PACK, Catalog Number SAN37ASMOF; 52) ACCESSORY PACK, Catalog Number SAN37ASMOG; 53) ACCESSORY PACK, Catalog Number SAN37ASMOH; 54) PEDIATRIC CARDIAC CATH PACK, Catalog Number SAN57PD00K; 55) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS10; 56) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS11; 57) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSM7; 58) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM8; 59) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM9; 60) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSMK; 61) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSML; 62) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSMN; 63) CATH PACK, Catalog Number SAN73CHS10; 64) CATH PACK, Catalog Number SAN73CHS11; 65) CATH PACK, Catalog Number SAN73CHSJ5; 66) CATH PACK, Catalog Number SAN73CHSJ6; 67) CATH PACK, Catalog Number SAN73CHSJ7; 68) CATH PACK, Catalog Number SAN73CHSJ8; 69) CATH PACK, Catalog Number SAN73CHSJ9; 70) CATH PACK, Catalog Number SAN73CHSJJ; 71) CATH PACK, Catalog Number SAN73CHSJK; 72) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSB; 73) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSC; 74) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGR4; 75) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRJ; 76) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRK; 77) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA13; 78) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA14; 79) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA15; 80) ANGIOGRAPHY DRAPE PACK CMC,
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D; e) VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG; f) ANGIO PACK-LF, Model Number DYNJ0373279M; g) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I; h) IPMC ANGIOGRAPHY PACK-LF, Model Number DYNJ0806254D; i) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485T; j) ANGIO DRAPE PACK, Model Number DYNJ17624B; k) DEPAUL ANGIO PACK, Model Number DYNJ19939M; l) EP ANGIOGRAPHY PACK, Model Number DYNJ24225K; m) ANGIOGRAPHY DRAPE PACK-LF, Model Number DYNJ28067G; n) DASHTI-YAO NEURO ANGIO-LF, Model Number DYNJ33457C; o) ANGIOGRAM TRAY, Model Number DYNJ33638K; p) ANGIO PACK, Model Number DYNJ34361; q) ANGIO/PICC PACK, Model Number DYNJ36049; r) IR MINOR ANGIO PACK, Model Number DYNJ37665B; s) ANGIO LEFT HEART PACK, Model Number DYNJ40632C; t) MV-IR ANGIO DRAPE PACK-LF, Model Number DYNJ41553D; u) CUSTOM ANGIO TRAY, Model Number DYNJ41649F; v) FS ANGIO, Model Number DYNJ42499C; w) ANGIO PACK, Model Number DYNJ42903B; x) ANGIO PACK, Model Number DYNJ43661B; y) ANGIOGRAPHY PACK, Model Number DYNJ44293D; z) ANGIO DRAPE PACK, Model Number DYNJ44320F; aa) ANGIOGRAM PACK, Model Number DYNJ45007; bb) ANGIO BASIN SET, Model Number DYNJ46043F; cc) ANGIO TRAY, Model Number DYNJ46153B; dd) ANGIOGRAM PACK, Model Number DYNJ47004C; ee) ANGIO PACK, Model Number DYNJ47226A; ff) ANGIOGRAPHY PACK, Model Number DYNJ47906; gg) ANGIO DRAPE SPEC PROC PACK-LF, Model Number DYNJ47951A; hh) MH HOOD CARDIAC ANGIO, Model Number DYNJ49884F; ii) ANGIO PACK, Model Number DYNJ50624A; jj) ANGIO PACK, Model Number DYNJ51239A; kk) ANGIO TRAY, Model Number DYNJ52121; ll) ANGIO PACK-LF, Model Number DYNJ52898C; mm) ANGIOGRAPHY PACK, Model Number DYNJ55252B; nn) ANGIOGRAPHY PACK, Model Number DYNJ57498; oo) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645B; pp) GENERAL ANGIO PACK, Model Number DYNJ57760B; qq) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792A; rr) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792B; ss) ANGIO PACK, Model Number DYNJ58126A; tt) HH ANGIO PACK, Model Number DYNJ59465B; uu) OR ANGIO PACK, Model Number DYNJ60319A; vv) ANGIO PACK 2-A, Model Number DYNJ60507A; ww) FEMORAL ANGIOGRAPY SET UP, Model Number DYNJ61015B; xx) ANGIO PACK, Model Number DYNJ62299; yy) CLOVIS CATH LAB PACK, Model Number DYNJ62379; zz) ANGIO PACK, Model Number DYNJ62544; aaa) ANGIO TRAY W/CHLORAPREP, Model Number DYNJ62742; bbb) OR ANGIO PAC , Model Number DYNJ63976A; ccc) SUNSHINE PAC , Model Number DYNJ64830; ddd) ANGIO PAC , Model Number DYNJ65043A; eee) CATH LAB PAC , Model Number DYNJ65185; fff) ANGIOGRAPHY PACK, Model Number DYNJ65190C; ggg) PACK,BASIC ANGIO, Model Number DYNJ65482A; hhh) ANGIO PACK, Model Number DYNJ66398B; iii) ANGIOGRAPHY PACK, Model Number DYNJ66476; jjj) SURGERY ANGIO PACK-LF, Model Number DYNJ66500; kkk) OR ANGIOGRAPHY PACK, Model Number DYNJ67245; lll) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065A; mmm) ANGIO TRAY, Model Number DYNJ68758; nnn) ANGIO, Model Number DYNJ902507B; ooo) ANGIOGRAPHY PACK, Model Number DYNJC2371G; ppp) ANGIOGRAPHY DRAPE PACK, Model Number DYNJT2344B; qqq) PEDI ANGIO PACK-LF, Model Number PHS41743D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F; e) NEURO IR PACK, Model Number DYNJ35066I; f) NEURO IR PACK, Model Number DYNJ35066J; g) IR NEURO PACK, Model Number DYNJ39198L; h) IR NEURO PACK, Model Number DYNJ39198N; i) BASIC PACK, Model Number DYNJ39752A; j) C.I.C.N. ANGIO PACK, Model Number DYNJ53064B; k) ANGIOGRAPHIC PACK, Model Number DYNJ57442C; l) ANGIO/VENO PACK, Model Number DYNJ58346A; m) NEURO RADIOLOGY PACK, Model Number DYNJ59903A; n) NEURO RADIOLOGY PACK, Model Number DYNJ59903B; o) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112A; p) NEURO IR PACK, Model Number DYNJ60701D; q) RADIOLOGY NEURO DRAPE PAC, Model Number DYNJ61449; r) NEURO PACK, Model Number DYNJ61798D; s) BASIC CATH/ANGIO, Model Number DYNJ62591A; t) ANGIOGRAPHIC PACK, Model Number DYNJ64081A; u) ANGIO PACK, Model Number DYNJ64676; v) ANGIOGRAPHY PACK, Model Number DYNJ65963; w) NEURO PACK, Model Number DYNJ66241A; x) NEURO PACK, Model Number DYNJ66241B; y) NEURO PACK, Model Number DYNJ66241C; z) NEURO PACK, Model Number DYNJ66241D; aa) NEURO ACCESSORY PACK, Model Number DYNJ66790A; bb) NEURO ACCESSORY PACK, Model Number DYNJ66790B; cc) NEURO TRAY, Model Number DYNJ67075A; dd) NEURO PACK, Model Number DYNJ68956A; ee) NEURO PACK, Model Number DYNJ68956B; ff) NEURO CATH PACK, Model Number DYNJ69129; gg) NEURO CATH PACK, Model Number DYNJ83090; hh) ANGIO, Model Number DYNJ905151A; ii) KIT OR AORTOGRM ANGIOPLAST PHT, Model Number DYNJ906086A; jj) ARTHROGRAM TRAY, Model Number SPEC0232
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245A; e) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245B; f) ARTERIAL LINE BUNDLE, Model Number ART255; g) ARTERIAL LINE BUNDLE, Model Number ART560; h) A LINE TRAY, Model Number ART690; i) ARTERIAL LINE TRAY, Model Number ART840; j) 18GX6" FEMORAL ART LINE KIT, Model Number ART960; k) 20Gx3" RADIAL ART LINE KIT, Model Number ART970; l) BIOPSY/ASPIRATION TRAY, Model Number BT235A; m) PERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825; n) PICC INSERTION KIT, Model Number CVI3735; o) PICC INSERTION BUNDLE, Model Number CVI4025A; p) VASCULAR ACCESS INSERTION KIT, Model Number CVI4180; q) VASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265; r) UNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430; s) PEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A; t) CVC ACCESSORY BUNDLE, Model Number CVI4505; u) DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655; v) FISHLINE KIT, Model Number CVI4725; w) VENOUS ACCESS TRAY, Model Number CVI4830A; x) VENOUS ACCESS TRAY, Model Number CVI4830B; y) CVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905; z) MVHS CVC LUMEN TRAY, Model Number CVI4920; aa) ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A; bb) ADULT VASCULAR ACCESS BUNDLE, Model Number DT22860; cc) TOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A; dd) MAX BARRIER KIT, Model Number DYND2673B; ee) THYROID FNA TRAY, Model Number DYNDA2238A; ff) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; gg) BASIC BIOPSY TRAY, Model Number DYNDH1534; hh) ULTRASOUND BIOPSY, Model Number DYNDH1542; ii) BIOPSY TRAY, Model Number DYNDH1661; jj) USG PIV KIT, Model Number DYNDV2536A; kk) ULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B; ll) PORT INSERTION KIT, Model Number MNS11590; mm) RADIOLOGY TRAY, Model Number MNS11625; nn) BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065; oo) INTRA PROBE COVER 5X96 KIT, Model Number P155598; pp) ULTRASOUND PROBE KIT, Model Number P482986; qq) ARTHROGRAM TRAY, Model Number SPEC0232; rr) ULTRA CORE BIOPSY KIT, Model Number SPEC0291B;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 19, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1847; j) ANESTHESIA BLOCK PACK - TBR, Model Number DYNJRA1864; k) 18G CPNB 20G STYLETED CATHETER, Model Number DYNJRA1869; l) NERVE BLOCK TRAY, Model Number DYNJRA1878; m) BLOCK KIT, Model Number DYNJRA1893; n) NERVE BLOCK TRAY, Model Number DYNJRA1900; o) US TPI KIT, Model Number DYNJRA1945; p) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1975; q) DR LEWIS US TRAY, Model Number DYNJRA1998; r) ULTRASOUND GUIDED NERVE BLOCK, Model Number DYNJRA2013; s) ULTRASOUND TRAY, Model Number DYNJRA2022; t) NERVE BLOCK INSERTION, Model Number DYNJRA2027; u) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028; v) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028A; w) PAIN TRAY, Model Number DYNJRA2041; x) SUPPORT TRAY, Model Number DYNJRA2044; y) SUPERFICIAL NERVE BLOCK, Model Number DYNJRA2086; z) NERVE BLOCK TRAY, Model Number DYNJRA2148; aa) TRAY 18G CPNB 20G STYLETED, Model Number DYNJRA9040; bb) ULTRASOUND BLOCK TRAY, Model Number DYNJRA9044; cc) PERIPHERAL NERVE CATHETER KT, Model Number PAIN1560; dd) PAIN PREP W/PROBE COVER TRAY, Model Number PAIN1762
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number DYNJ44322I; e) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D; f) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F; g) IR ARM PACK, Model Number DYNJ50712C; h) HYBRID PACK, Model Number DYNJ56907D; i) TUNNEL PACK, Model Number DYNJ58127B; j) CRANIOTOMY PACK, Model Number DYNJ61749A; k) CARPAL TUNNEL KIT, Model Number DYNJ63149A; l) ANGIOGRAPHY PACK, Model Number DYNJ65963A; m) ARTHROSCOPY PACK, Model Number DYNJ66402; n) ARTHROSCOPY PACK, Model Number DYNJ66402A; o) ARTHROSCOPY PACK, Model Number DYNJ66402C; p) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404; q) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404A; r) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404B; s) ARTHROSCOPY PACK, Model Number DYNJ68997; t) MURRIETA PACK, Model Number DYNJ69312; u) MURRIETA PACK, Model Number DYNJ69312A; v) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ82077; w) SCO ARTHROSCOPY, Model Number DYNJ906551A; x) US JOINT KIT, Model Number DYNJRA1944; y) HIP FRACTURE NERVE BLOCK, Model Number DYNJRA2085; z) ENS STERILE POUR IMPLANT-LF, Model Number OST011E; aa) ARTHROGRAM TRAY, Model Number PAIN1524C; bb) SHOULDER PACK-LF, Model Number PHS41748D; cc) LOWER EXTREMITY BLOCK PACK-RX, Model Number SPEC0204D; dd) UPPER EXTREMITY BLOCK PACK-RX, Model Number SPEC0205F;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023