FDA-Device2021-08-18Class I
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
BioMedical Equipment Service Co (BMES)
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
The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.
Affected count
718 potentially affected pumps
Manufactured in
2709 S Park Rd, N/A, Louisville, KY, United States
Products
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2204-2021Don't want to check this manually?
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