Device product
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
Z-3013-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3013-2024
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: DYNJ42742D , Lot Number 19ABF928 ; DYNJ42742D , Lot Number 19BBC938 ; DYNJ42742D , Lot Number 19PBB060 ; DYNJ42742D , Lot Number 19GBO530 ; DYNJ42742D , Lot Number 19HBH965 ; DYNJ42742D , Lot Number 19HBJ692 ; DYNJ42799, Lot Number 21GBH529 ; DYNJ42799, Lot Number 19CBO493 ; DYNJ42799, Lot Number 19EBF614 ; DYNJ42799, Lot Number 19FBD772 ; DYNJ42799, Lot Number 19GBE887 ; DYNJ42799, Lot Number 19HBI404 ; DYNJ42799, Lot Number 19IBT472 ; DYNJ42799, Lot Number 20ABD578 ; DYNJ42799, Lot Number 20CBF124 ; DYNJ42799, Lot Number 20DBC424 ; DYNJ42799, Lot Number 20EBT962 ; DYNJ42799, Lot Number 20JBF487 ; DYNJ42799, Lot Number 20JBZ120 ; DYNJ42799, Lot Number 21ABV059 ; DYNJ42799, Lot Number 21BBM615 ; DYNJ42799, Lot Number 21EBP168 ; DYNJ42799, Lot Number 21EBP171
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.