Question 1

What product was recalled?

Accepted Answer

Medline convenience kits labeled as:   1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ;  2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG;  3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI;  4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;  5) CATH LAB PACK , Pack Number 00-398725AM;  6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ;  7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ;  8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ;  9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ;  10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ;  11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ;  12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC;  13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD;  14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ;  15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ;  16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ;  17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ;  18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ;  19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ;  20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ;  21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ;  22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ;  23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ;  24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ;  25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ;  26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ;  27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ;  28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA;  29) CATH LAB PACK-LF, Pack Number 00-HCT055P ;  30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G;  31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I;  32) ANGIO PACK, Pack Number 0M-CP31933C;  33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I;  34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J;  35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ;  36) CABG 1, Pack Number CDS983663J ;  37) CATH CDS, Pack Number CDS984141I ;  38) ENDO AAA, Pack Number CDS984264I ;  39) ANGIOGRAPHY OR, Pack Number CDS984944C ;  40) ACCESS CATHETER , Pack Number CDS985507F ;  41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ;  42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ;  43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ;  44) NEURO ANGIO PACK, Pack Number DYNDA1431A;  45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ;  46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ;  47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ;  48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ;  49) ANGIOGRAM , Pack Number DYNJ0149444J ;  50) ANGIOGRAM , Pack Number DYNJ0149444K ;  51) ANGIOGRAM , Pack Number DYNJ0149444M ;  52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ;  53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ;  54) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  61) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  67) CATH PACK-LF, Pack Number DYNJ0367643Q ;  68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ;  75) ANGIO PACK-LF , Pack Number DYNJ0373279M ;  76) INTERVENTIO. Recalled by MEDLINE INDUSTRIES, LP - Northfield.

Question 2

Why was this product recalled?

Accepted Answer

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Question 3

Which agency issued this recall?

Accepted Answer

This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-2992-2024.

Product Description

Reason for Recall

Details

Frequently Asked Questions

Related Recalls

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Explore Related Data