Device product
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250
Z-3040-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3040-2024
Official wording
Reason: 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.
Code information: CHT2120, Lot Number 23DLA374 ; CHT2120, Lot Number 23ELA871 ; CHT2120, Lot Number 23FLA655 ; DYNDA2475, Lot Number 22IMA813 ; DYNDA2941A , Lot Number 23BMB940 ; DYNDA2941A , Lot Number 23FMF503 ; DYNDA2998, Lot Number 22KBB005 ; DYNDA2998, Lot Number 23BBD525 ; DYNDH1794, Lot Number 22LBM374 ; DYNDH1794, Lot Number 23EBL615 ; DYNDH1794, Lot Number 23LMF847 ; DYNDH1794H , Lot Number 23LMF847 ; DYNDH1794H , Lot Number 22LBM374 ; DYNDH1794H , Lot Number 23EBL615 ; DYNJ04474F , Lot Number 22JLA750 ; DYNJ04474F , Lot Number 23BLA545 ; DYNJ04474F , Lot Number 23FLA171 ; DYNJ66222B , Lot Number 24ALA413 ; DYNJ66222B , Lot Number 24ALA509 ; DYNJ66222B , Lot Number 24CLA156 ; DYNJ67988A , Lot Number 22JMG867 ; DYNJ67988A , Lot Number 22LMI605 ; DYNJ67988A , Lot Number 23AMJ359 ; DYNJ67988A , Lot Number 23DMG616 ; DYNJ67988A , Lot Number 23EMI610 ; DYNJ67988A , Lot Number 23GMB085 ; DYNJ67988A , Lot Number 23IMH819 ; DYNJ67988A , Lot Number 23KMF739 ; DYNJ83950, Lot Number 23CBG610 ; DYNJ83950, Lot Number 23FBF248 ; DYNJ83950, Lot Number 23LBR075 ; DYNJ85264, Lot Number 23KBE782 ; DYNJ904606C, Lot Number 23HBP402 ; DYNJ904606C, Lot Number 23IBS124 ; DYNJ904606C, Lot Number 23JBN042 ; DYNJ904606C, Lot Number 23KBW145 ; MNS15250 , Lot Number 24AMC318
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.