Question 1

What product was recalled?

Accepted Answer

Medline procedure packs containing Shenli syringes, labeled as follows: 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) no name , Pack Number DYNJ0161241F ;  55) ANGIO PACK-LF , Pack Number DYNJ0165039M ;  56) ANGIO PACK-LF , Pack Number DYNJ0165039N ;  57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF;  58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG;  59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG;  60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ;  61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ;  62) ANGIO PACK-LF , Pack Number DYNJ0281048I ;  63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ;  64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG;  65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ;  66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ;  67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ;  68) CATH PACK-LF, Pack Number DYNJ0367643Q ;  69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ;  70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ;  71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ;  72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ;  73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ;  74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ;  75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1,679,067 units in total.

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 4, 2024. Severity: Moderate. Recall number: Z-2627-2024.

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Reason for Recall

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