43 results
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7ms
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Sources: EU EUDAMED, US FDA
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Enforcement
Class II
·Completed·Materialise USA LLC·August 31, 2022
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·November 2, 2016
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·August 21, 2013
Z-1477-2022
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710; ddd. CV ACCESS PACK WRO-LF, Model Number: DYNJ41875B; eee. CV CDS, Model Number: CDS985395C; fff. CV MINOR CDS, Model Number: CDS984100T; ggg. CV PACK, Model Number: DYNJ45074B; hhh. CVC PACK, Model Number: DYNJ44010; iii. CVL PACK, Model Number: DYNJ00281N; jjj. CVOR CDS-LF, Model Number: CDS840198V; kkk. CYSTO PACK SMGH-LF, Model Number: DYNJ41915A; lll. DAVIES PHALLOPLASTY PACK, Model Number: DYNJ52185F; mmm. DAVINCI, Model Number: DYNJ906543A; nnn. DBD-BASIC PACK, Model Number: DYNJ55458; ooo. DBD-BIOPSY PACK-LF, Model Number: DYNJ0747885F; ppp. DBD-DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069M; qqq. DBD-ECMO MODULE PACK, Model Number: DYNJ55669F; rrr. DBD-EVLA PACK, Model Number: DYNJ6
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
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) 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
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
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) 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