Recall Z-1332-2021 ยท FRN Pump, Infusion
Tenacore LLC
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
| Date | Apr 2, 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 | On 02/25/2021, Field Safety Corrective Action notifications were mailed to customers; customers were also notified via phone. The recalling firm provided the following services to customers: serviced infusion pumps, sold infusion pumps, and sold bezel repair parts. Customers were asked to do the following: 1. Review the serialized list of potentially impacted pumps and remove these devices from clinical use and immediately quarantine them until they can be inspected, and impacted parts are replaced, if necessary. Part customers were told to quarantine affected parts. 2. Inspect the poten |
| Quantity | 1494 |
| Distribution | US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, 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 |