Recall Z-3141-2024 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
| Date | Sep 13, 2024 (initiated Aug 15, 2024) |
| Status | Open, Classified |
| Reason | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| Root cause | Process control |
| Action | On 08/15/2024, the firm sent an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" Letter via FedEx /2-day or email to customers informing them that, BD has identified an increase in bent contacts on the new Female/Left IUI connectors which may cause delays in initiating therapy. Customer are instructed to: 1. Per current labeling, customers should inspect all IUI connectors prior to use. You may also refer to Appendix A for further details. 2. If you identify a bent/lifted IUI pin prior to use, do not use the device and send the device to biomedical engineering or Qualified Service Personnel for rep |
| Quantity | 20145 |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries |
| 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 |