Class II
Medical Device Recall: 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.
MEDLINE INDUSTRIES, LP - Northfield · February 13, 2025
Reason for Recall
Potential breach in pouch packaging which could lead to loss of sterility.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
2,422 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1368-2025
Status: ongoing
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