Tenacore LLC recalls Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part

Recall date

February 25, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1331-2021

FDA classification

Class I

Brand / firm

Tenacore LLC

Sold / distributed

US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part