Recall Z-3080-2026 ยท FPA Set, Administration, Intravascular
BD SWITZERLAND SARL
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves,
| Date | Sep 15, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance. |
| Root cause | Device Design |
| Action | On 08/19/2026, an "URGENT MEDICAL DEVICE CORRECTION" letter was sent via FedEx and other courier services informing customers that, the BD Alaris" Pump Module Model 8100, when used with some BD Alaris" Pump Infusion Sets at low flow rates or to deliver low bolus volumes, may perform worse than previously disclosed. Due to the difficulty in recognizing these performance issues, users may fail to identify them as the cause of clinically significant changes in a patient's condition. Performance attributes that differ from previously communicated values have the potential to result in greater degr |
| Quantity | 94,230,757 |
| Distribution | U.S.: Nation-wide - 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, 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, and WY. O.U.S.: Australia Belgium Bahrain Botswana Canada Cuba Chi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS Alaris Medical Systems, Inc., Aug 6, 2002 |