Recall Z-2941-2026 ยท FPA Set, Administration, Intravascular
BD SWITZERLAND SARL
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter
| Date | Aug 13, 2026 (initiated Jun 16, 2026) |
| Status | Open, Classified |
| Reason | Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly. |
| Root cause | Process control |
| Action | On 06/16/2026, an "URGENT: Medical Device Recall" Letter was emailed to customers informing them that, BD has identified a mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in product not being sterilized correctly. Customer are instructed to: "Immediately discontinue use of the affected lot(s). "Check all inventory locations within your facility and destroy all affected units in accordance with your facility s process. If destruction is not immediately possible at your facility, then product should |
| Quantity | 93,700 |
| Distribution | U.S.: AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA O.U.S.: Canada |
| FDA record | Open on fda.gov |