Device product
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
Z-2452-2026
Product summary
- Event
- Event 99043
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 227 units
- Official record key
device-enforcement:Z-2452-2026
Official wording
Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Code information: 1) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24GBR740; 2) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24JBP984; 3) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26DBJ110; 4) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABJ069; 5) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABL749; 6) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25CBB762; 7) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25DBG799; 8) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25EBM994; 9) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25GBW226; 10) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBA950; 11) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25LBT019; 12) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABH519; 13) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26ABT315; 14) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26BBQ338
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.