Device product
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.
Z-1364-2025
Product summary
- Event
- Event 96401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,490 units
- Official record key
device-enforcement:Z-1364-2025
Official wording
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Code information: Item No. DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A; UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416; UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415; Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Sterility assurance
loss of sterility