Device product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Z-1365-2025
Product summary
- Event
- Event 96401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 114 units
- Official record key
device-enforcement:Z-1365-2025
Official wording
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Code information: Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). .
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
loss of sterility