Recall Z-1231-2025 ยท FRN Pump, Infusion
CareFusion 303, Inc.
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration
| Date | Feb 24, 2025 (initiated Jan 23, 2025) |
| Status | Open, Classified |
| Reason | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open. |
| Root cause | Under Investigation by firm |
| Action | On 01/23/2025, the firm sent via FedEx, 2-day mail and email an "URGENT MEDICAL DEVICE LABELING CORRECTION" Letter to customers informing them that Through an internal review, BD has identified that in the BD Alaris" System User Manual v 12.3.1 (p/n #P00000455), 12.3.2 (p/n# P00000827) and 12.4 (p/n# P00000828), there is an incorrect note on the Pump Module Set Loading instructions. The manuals incorrectly instruct users to leave the safety clamp in the open position when reloading an infusion set. The correct procedure is to leave the safety clamp in the closed position. Following the incorre |
| Quantity | 242,098 systems |
| Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba O.U.S.: Canada |
| 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 |