Device product
ASM Replacement Battery, Component Number SUB0000864
Z-1567-2023
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 91874
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 9984 units
- Official record key
device-enforcement:Z-1567-2023
Official wording
Reason: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Code information: Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757
Distribution pattern: worldwide
Derived failure modes
-
Manufacturing or process control
manufacturing defect