Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYND
FDA device recall Z-1366-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Action taken
- 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 form. Website link: https://recalls.medline.com Recall Reference #: R-25-262 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 926,227 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Bahamas.
- Date initiated
- 2025-12-31
- Date posted
- 2026-02-13
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I.V. Administration Set (K242126) | Bq Plus Medical Co., Ltd. | 2024-08-22 |