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The Biomed Guys recalls Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA
Recalled June 9, 2021 · FDA recall Z-1651-2021 · The Biomed Guys
Hazard
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion. · FDA Class I
Units
22 units
Sold at
Us distribution to the states of IN and TX.
Description
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Manufacturer(s)
The Biomed Guys
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →