Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
FDA Recall #Z-2324-2025 — Class III — June 4, 2025
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.
Recalling Firm
Diversatek Healthcare — Highlands Ranch, CO
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
8
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated