Recall Z-1705-2025 ยท FRO Dressing, Wound, Drug
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Water, USP, 100mL, REF RDI30295
| 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 | 963054 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
| K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Medline Industries, Inc., Jul 2, 2018 |