Recall Z-0430-2026 ยท FRN Pump, Infusion
CareFusion 303, Inc.
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
| Date | Nov 20, 2025 (initiated Oct 17, 2025) |
| Status | Open, Classified |
| Reason | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated. |
| Root cause | Device Design |
| Action | On 10/17/2025, correction notices were mailed and emailed: Distribute notice to clinical and non-clinical users. Safety Reminder: https://academy.bd.com/en-us/home. Provide notice to any facilities you may have sold or transferred devices to. Use only BD-authorized companies when renting infusion devices. Complete and return response form to bdrc55@bd.com If dropped, biomedical engineering should perform testing as specified in Level of Testing Guidelines, including rate accuracy verification testing. If any test fails see troubleshooting section, see Technical Service Manual, Chapter 5 and |
| Quantity | 2,574,396 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR. |
| 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 |