FDAHealthJune 4, 2025
Diversatek Healthcare — Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 4, 2025
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
What's affected?
- Product
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Lot code
- 24752
Additional details
UDI-DI: 00816734022863, Lot: 24752
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 8.
Get Health recall alerts
Delivered to your inbox. Free. No account required.