Device product
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Z-1566-2023
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 91874
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 23815 units
- Official record key
device-enforcement:Z-1566-2023
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