Device product
Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
Z-2991-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2991-2024
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: DYNJ41223, Lot Number 21HBU861 ; DYNJ41223, Lot Number 21KBA848 ; DYNJ41223, Lot Number 21KBA910 ; DYNJ41223, Lot Number 22ABA546 ; DYNJ41223, Lot Number 22MBA262 ; DYNJ41223, Lot Number 19BBC903 ; DYNJ41223, Lot Number 19CBO901 ; DYNJ41223, Lot Number 19DBW422 ; DYNJ41223, Lot Number 22HBY065 ; DYNJ41223, Lot Number 19HBD957 ; DYNJ41223, Lot Number 19HBJ856 ; DYNJ41223, Lot Number 19IBT476 ; DYNJ41223, Lot Number 22KBU048 ; DYNJ41223, Lot Number 19VBD385 ; DYNJ41223, Lot Number 19LBF954 ; DYNJ41223, Lot Number 23EBC280 ; DYNJ41223, Lot Number 23FBA251 ; DYNJ41223, Lot Number 20BBP883 ; DYNJ41223, Lot Number 20CBI263 ; DYNJ41223, Lot Number 23JBC138 ; DYNJ41223, Lot Number 23KBO541 ; DYNJ41223, Lot Number 20IBJ759 ; DYNJ41223, Lot Number 20JBE058 ; DYNJ41223, Lot Number 20XBF374
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.