Class II
Medical Device Recall: Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. 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
220 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1369-2025
Status: ongoing
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