Device product
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Z-1824-2026
Product summary
- Event
- Event 98626
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 640 kits
- Official record key
device-enforcement:Z-1824-2026
Official wording
Reason: On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Code information: Medline Kit Number/SKU CIT7050F, UDI/DI each 10198459536656, UDI/DI case 40198459536657, Lot Number 25KLA002
Distribution pattern: US Nationwide distribution in the state of South Carolina.
Derived failure modes
-
Unknown
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.