Device product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Z-1565-2023
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 91874
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 28656 units
- Official record key
device-enforcement:Z-1565-2023
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: All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
Distribution pattern: worldwide
Derived failure modes
-
Manufacturing or process control
manufacturing defect