Device product
Custom Procedure Kit, REF: K12T-11077
Z-3191-2024
Product summary
- Event
- Event 95234
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-3191-2024
Official wording
Reason: 7F sheath introducers labeled as 7.5F
Code information: REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024)
Distribution pattern: Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
Derived failure modes
-
Unknown
7F sheath introducers labeled as 7.5F