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Open, Classified

Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part

FDA Recall Z-1544-2021 · Posted None

Recalling FirmInfusion Pump Repair
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2021-03-26
Product Quantity15

Reason for Recall

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.

Firm 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 Response Form. Customers can contact the recalling firm at: 855-477-8866 or [email protected]

Root Cause

Component design/selection

Distribution Pattern

California

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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