Recall Z-1711-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1711-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-19

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.. 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-03-19
Firm location: Northfield, IL, United States

Product description

Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.