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Recall Observatory FDA recall evidence

Device product

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Z-2324-2025

June 04, 2025

Class III

Product summary

Firm
Diversatek Healthcare
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

    reason.labeling_packaging · v1.0.0

    mislabeled