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Terminated

Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

FDA Recall Z-1543-2021 · Posted 2021-05-10

Recalling FirmSTEP-HAR MEDICAL LLC
Recall StatusTerminated
Product CodeFRN
Date Initiated2021-02-26
Date Terminated2024-08-15
Product Quantity2

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 02/26/2021, the one customer was notified of the recall via phone call and email. On 04/15/21, a Voluntary Field Safety Corrective Action notice were mailed. The firm asked their customer to respond so the bezel repair part could be replaced. Customers can contact the recalling firm at: 657-267-0054 or [email protected]

Root Cause

Component design/selection

Distribution Pattern

IA

Official Source

View FDA Recall →

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

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