FDA-Device2025-08-20Class III
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Diversatek Healthcare
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.
Sold states
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Affected count
8
Manufactured in
9150 Commerce Center Cir Ste 500, N/A, Highlands Ranch, CO, United States
Products
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2025Don't want to check this manually?
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