Recall Z-1375-2021 ยท FRN Pump, Infusion
Pacific Medical Group Inc.
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
| Date | Mar 24, 2021 |
| Status | Open, Classified |
| Reason | Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion. |
| Root cause | Component design/selection |
| Action | On 03/24/2021, Medical Device Recall Notifications were emailed to customers. Customers were asked to take the following actions: If you have affected product, remove these devices from clinical use and immediately quarantine them until the impacted parts can be returned to the recalling firm; contact Customer Service 800-449-5328, pm.recallapm@avantehs.com. The recall part number is RCL2021-823-01. Once returned, the affected device will be evaluated and inspected and where the component under recall is identified, it will be replaced by our organization with the OEM component and then retur |
| Quantity | 2452 |
| Distribution | Distribution US nationwide. |
| 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 |