Recall Z-2430-2023 ยท FRN Pump, Infusion
ICU Medical Inc
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213, 300105413, 300105713, 300106313, 300106513, 300106581, 300107813, 300107814, 300108513, 300108813, 3001088
| Date | Aug 18, 2023 (initiated Jul 13, 2023) |
| Status | Open, Classified |
| Reason | Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. |
| Root cause | Nonconforming Material/Component |
| Action | ICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 07/13/2023 via traceable mailing. The notice explained the issue, potential risk, and requested the following: Actions for Clinical Users: If your Plum 360 pump does not power on or indicates an Audio Alarm failure, please remove the pump from use and send the pump to Biomedical Engineering. Actions for Biomedical Engineering: If you have Plum 360 pumps with Audio Alarm failures, please contact ICU Medical. 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediatel |
| Quantity | 93135 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |