Device product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Z-1366-2025
Product summary
- Event
- Event 96401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 506 units
- Official record key
device-enforcement:Z-1366-2025
Official wording
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Code information: Item No. DYNJ34603F & DYNJ903916I; UDI (case): 40198459143596 & 40195327580118; UDI (each): 10198459143595 & 10195327580117; Lot No. (Shelf Life) 25AMD464(11/30/2029), 24JMC011(04/30/2029), 25ABA362(09/30/2025), 24KBT718(02/28/2026), 24JBE997(09/30/2025), 24IBM203(02/28/2026).
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
loss of sterility