Device product
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Z-1369-2025
Product summary
- Event
- Event 96401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 220 units
- Official record key
device-enforcement:Z-1369-2025
Official wording
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Code information: Item No. DYNJ53968P; UDI (case): 40195327532759; UDI (each): 10195327532758; Lot No. (Shelf Life) 24KMC372 (3/31/2026), 24IMJ082 (4/30/2026), 24HMK377 (4/30/2026). .
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
loss of sterility