Recall Z-1567-2023 ยท FRN Pump, Infusion
ICU Medical Inc
ASM Replacement Battery, Component Number SUB0000864
| Date | May 16, 2023 (initiated Mar 22, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | ICU medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 03/22/2023 to its direct and indirect consignees by mail. The notice explained the issue and the hazard and requested the following: Clinical Users: Whenever possible, keep the pump plugged into AC power. Before disconnecting the pump from AC power, please ensure that the battery is fully charged. Closely monitor the Battery Status Indicator while the pump is disconnected from AC power. Additionally, have a backup pump available when infusing critical medications. Biomedical Engineering: You may replace affected batteries |
| Quantity | 9984 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.