FDA recall Z-1358-2018
Aesculap Implant Systems LLC · Class III · device
Product
Doyen-Collin Mouth Gag 120MM/ General Instruments
Reason for recall
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Distribution
nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-02-16
- Report date
- 2018-04-18
- Termination date
- 2020-06-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2018