FDA recall Z-1367-2025
MEDLINE INDUSTRIES, LP - Northfield · Class II · device
Product
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Reason for recall
Potential breach in pouch packaging which could lead to loss of sterility.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-02-13
- Report date
- 2025-03-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2025