FDA-Device2021-06-09Class I
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
The Biomed Guys
Hazard
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
Sold states
Us distribution to the states of IN and TX.
Affected count
22 units
Manufactured in
1865 Ashland City Rd Ste H, Clarksville, TN, United States
Products
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2021Don't want to check this manually?
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