FDA-Device2021-05-19Class I
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
STEP-HAR MEDICAL LLC
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.
Sold states
IA
Affected count
2
Manufactured in
11237 Slater Ave, Fountain Valley, CA, United States
Products
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2021Don't want to check this manually?
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