60 results
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6ms
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Sources: EU EUDAMED, US FDA
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·March 18, 2020
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·April 27, 2022
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·April 27, 2022
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·June 17, 2020
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·February 3, 2021
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·September 7, 2022
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·September 7, 2022
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·September 7, 2022
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·October 11, 2023
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015
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