Z-2324-2025 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- June 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Code Information
UDI-DI: 00816734022863, Lot: 24752