HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
FDA Recall #Z-1333-2025 — Class II — February 6, 2025
Product Description
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
388 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072193483 Lots 962241 914241 70-050890 70-051579 70-052206 70-053085
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated