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Tenacore LLC recalls Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Recalled April 14, 2021 · FDA recall Z-1332-2021 · Tenacore
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
1494
Sold at
US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, 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 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Manufacturer(s)
Tenacore LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →