FDAFebruary 25, 2021device
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
tenacore
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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