Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Recall
- Recall Number
- Z-1544-2021
- Event Number
- 87657
- Firm
- Infusion Pump Repair
- FEI Number
- 3011655432
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- March 26, 2021
- Address
- 18 Technology Dr, Ste 133, Irvine, CA, 92618-2311
Description
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
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.
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 Response Form. Customers can contact the recalling firm at: 855-477-8866 or [email protected]
California
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