FDA recall Z-1365-2025
MEDLINE INDUSTRIES, LP - Northfield · Class II · device
Product
Proxima Drape labeled as ENT-PLASTICS PACK. 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-1365-2025