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FDA (Device enforcement)Recalled 2025-06-04class iii

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

Hazard

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.

Details from the source

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: Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea. Quantity: 8 Lot/code info: UDI-DI: 00816734022863, Lot: 24752

UPC codes

00816734022863

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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