ICU Medical Inc Recall 91874
Description: Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
ICU Medical Inc Recall 91874 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1565-2023 |
Event ID | 91874 |
Event Description | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 |
Product Type | Devices |
Distribution | worldwide |
Quantity | 28656 units |
Recall 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. |
Device Classification | 20230524 |
Device Code Info | All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower |
Center Classification Date | 20230516 |
Recall Initiation Date | 20230322 |
Recalling Firm | ICU Medical Inc |
Initial Notification | Letter |
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