Recall Z-2204-2021 ยท FRN Pump, Infusion
BioMedical Equipment Service Co (BMES)
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
| Date | Aug 6, 2021 (initiated Feb 25, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | Recall notification emails were sent to customers beginning 2/25/21. The emails stated the following: We have been notified by the FDA and our distributor about a voluntary part recall, to address potential performance concerns for a bezel part used in the service and repair of Alaris Pump Module 8100. The bezel part subject to this corrective action was used in the service and repair of the Alaris Pump Module 8100 between July 10, 2020 and February 18, 2021. The part is from a distributor and is not a BMES part. We have switched distributors since learning of the issue. While it's list |
| Quantity | 718 potentially affected pumps |
| Distribution | The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX Carefusion 303, Inc., Aug 21, 2014 |