Device product
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Z-1367-2025
Product summary
- Event
- Event 96401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-1367-2025
Official wording
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Code information: Item No.DYNJ910462; UDI (case): 40195327695638; UDI (each): 10195327695637; Lot No. (Shelf Life) 24JMD608 (06/30/2026).
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
loss of sterility