Reported Jun 9, 2021 · Ongoing
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part,…
The Biomed Guys
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Biomed Guys · 1865 Ashland City Rd Ste H · Clarksville, TN · 37043-6455
Is this the product you have?
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
- Lot codes and dates
- Serial numbers of serviced devices
- serviced 09/2020-02-2021
12833065131870211318781112838069129825091283723112835186128379721271059312776790137538931360591912832544157635261480620314806612148070701373843215763547158656261480647212796415
- Amount recalled
- 22 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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