Recall Z-1711-2025 ยท MCY Wound Dressing Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
| Date | May 1, 2025 (initiated Mar 19, 2025) |
| Status | Open, Classified |
| Reason | It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email Recalls@Medline.com. |
| Quantity | 5200 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Panama and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.