Device product
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Z-1371-2022
Product summary
- Event
- Event 90438
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 163 cases
- Official record key
device-enforcement:Z-1371-2022
Official wording
Reason: Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
Code information: UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31
Distribution pattern: Natiowide
Derived failure modes
-
Unknown
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use