Device product
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Z-1333-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 388 kits
- Official record key
device-enforcement:Z-1333-2025
Official wording
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Code information: UDI-DI 00191072193483 Lots 962241 914241 70-050890 70-051579 70-052206 70-053085
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.