Recall Z-1995-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1995-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-15

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250. Reason: There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-05-15
Firm location: Northfield, IL, United States

Product description

Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

Reason for recall

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

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