FDA-Device2025-03-26Class II
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
Hazard
Potential breach in pouch packaging which could lead to loss of sterility.
Sold states
US Nationwide distribution.
Affected count
2,422 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2025Don't want to check this manually?
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