FDA-Device2025-03-26Class II
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Hazard
Potential breach in pouch packaging which could lead to loss of sterility.
Sold states
US Nationwide distribution.
Affected count
506 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2025Don't want to check this manually?
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