Z-1567-2023 Class I Ongoing
FDA device recall Z-1567-2023 was initiated by ICU Medical Inc on March 22, 2023 and is designated Class I. Reason for recall: 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 ea… The recall status is ongoing. Affected quantity: 9984 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9984 units
Product Description
ASM Replacement Battery, Component Number SUB0000864
Reason for Recall
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.
Distribution Pattern
worldwide
Code Information
Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757