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BioMedical Equipment Service Co (BMES) recalls Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted b
Recalled August 18, 2021 · FDA recall Z-2204-2021 · BioMedical Equipment Service Co (BMES)
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. · FDA Class I
Units
718 potentially affected pumps
Sold at
The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.
Description
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.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Manufacturer(s)
BioMedical Equipment Service Co (BMES)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →