Device product
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Z-2324-2025
Product summary
- Event
- Event 97282
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 8
- Official record key
device-enforcement:Z-2324-2025
Official wording
Reason: Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
Code information: UDI-DI: 00816734022863, Lot: 24752
Distribution pattern: Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Derived failure modes
-
Labeling or packaging
mislabeled