Recall Z-1368-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1368-2025
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. It names one FDA 510(k) clearance: K213481. Product: Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. 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

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. 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.