Reported Aug 18, 2021 · Terminated
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted…
BioMedical Equipment Service Co. (BMES)
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: BioMedical Equipment Service Co (BMES) · 2709 S Park Rd · Louisville, KY · 40219-3645
Is this the product you have?
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
- Lot codes and dates
- Serial Numbers
719 of 719 codes
1341413813414659134148291341584315221825152218251274434112835089128619901287591812959808130774101307741313077474136814071530639615306899124206461242116912635894127814981294951013367664134152161393195420001893000595300088330608003114560316306231694973704252370426837043223704343370436637044763704477370448537045293704536370454937046393704645370481037048143704853410972041102778000560988587899235939923615992367199238009928207139002701389511313895704
- Serial Numbers
- Amount recalled
- 718 potentially affected pumps
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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