Device product
Aligned Medical AMS16835 Fluids Kit RX
Z-2307-2026
Product summary
- Event
- Event 98957
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 875 kits
- Official record key
device-enforcement:Z-2307-2026
Official wording
Reason: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Code information: UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Distribution pattern: US Nationwide distribution in the states of IL, VA.
Derived failure modes
-
Unknown
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.