Device product
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Z-1128-2025
Product summary
- Event
- Event 95947
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 973,785 total units
- Official record key
device-enforcement:Z-1128-2025
Official wording
Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Code information: 1) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7266123 ; 2) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7331357 ; 3) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7266123 ; 4) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333452 ; 5) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333453 ; 6) SOT4FRUWFC, UDI-DI:10197106732304 (each) 50197106732302 (case), Lot Number: 7350031 ;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Derived failure modes
-
Unknown
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.