FDAFebruary 25, 2021device

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

biomedical equipment service co bmesbiomedicalbiomedical equipment

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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