Recall Z-1366-2026 ยท FPA Set, Administration, Intravascular
Medline Industries, LP
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539;
| Date | Feb 13, 2026 (initiated Dec 31, 2025) |
| Status | Open, Classified |
| Reason | Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 12/31/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response |
| Quantity | 926,227 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242126 | I.V. Administration Set Bq Plus Medical Co., Ltd., Aug 22, 2024 |