FDA-Device2025-03-26Class II
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
American Contract Systems Inc
Hazard
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Sold states
US Nationwide distribution in the state of OH.
Affected count
388 kits
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1333-2025Don't want to check this manually?
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