Recall Z-2179-2025 ยท FRN Pump, Infusion
CareFusion 303, Inc.
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
| Date | Aug 6, 2025 (initiated Jul 8, 2025) |
| Status | Open, Classified |
| Reason | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. |
| Root cause | Under Investigation by firm |
| Action | On December 12, 2025, CareFusion 303, Inc. (BD) issued a updated "Urgent Medical device Recall Notice via E-Mail and physical mail. The updated notice includes important information on infusion sets as well as labeling updates. Previous notifications were sent on July 8,2025, July 17, 2025, September 11, 2025 and September 12, 2025. CareFusion ask consignees to take the following actions: 1. Review your inventory for the catalog numbers included in the updated letter. Remove and discard any remaining inventory per your facility guidelines. 2.To receive credit or replacement product, please r |
| Quantity | 33,162,680 units total |
| Distribution | US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 Carefusion 303, Inc., Jul 21, 2023 |