Recall Z-1544-2021 ยท FRN Pump, Infusion
Infusion Pump Repair
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
| Date | Mar 26, 2021 |
| Status | Open, Classified |
| Reason | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion. |
| Root cause | Component design/selection |
| Action | On 03/26/2021, Voluntary Field Safety Corrective Action notices started being mailed to customers. The firm conducted further communications via email and phone. The firm asked customers with pumps serviced with the affected bezels to return the pump module units to the recalling firm so they could swap out the affected bezels or provide a refund. The firm asked customers to immediately share this field safety corrective action notification with all necessary parties within your organization to ensure that they are also aware of this action. Also, please complete and return the Customer Respo |
| Quantity | 15 |
| Distribution | California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc., Aug 21, 2014 |