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STEP-HAR MEDICAL LLC recalls Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Recalled May 19, 2021 · FDA recall Z-1543-2021 · STEP-HAR MEDICAL
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
2
Sold at
IA
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 Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Manufacturer(s)
STEP-HAR MEDICAL LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →