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.
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
00816734022863
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.