Recall Z-1370-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1370-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-13

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.. Reason: Potential breach in pouch packaging which could lead to loss of sterility..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-02-13
Firm location: Northfield, IL, United States

Product description

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

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