Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

Recall Insight

This FDA Devices action (record #Z-2204-2021) was formally reported on August 18, 2021, with the manufacturer initiating the action on February 25, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. BioMedical Equipment Service Co (BMES) is listed as the recalling firm, operating out of Louisville, KY. Federal records indicate 718 potentially affected pumps units are affected.

The documented reason for this recall is: 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 re… Distribution data in the federal record shows the product reached: The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.