Device product
Doyen-Collin Mouth Gag 120MM/ General Instruments
Z-1358-2018
Product summary
- Event
- Event 79656
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1358-2018
Official wording
Reason: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Code information: OM040R
Distribution pattern: nationwide
Derived failure modes
-
Unknown
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.