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Tenacore LLC recalls Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Recalled April 14, 2021 · FDA recall Z-1331-2021 · 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
474
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 Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Manufacturer(s)
Tenacore LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →