Device product
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Z-0001-2016
Product summary
- Event
- Event 71987
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-0001-2016
Official wording
Reason: The company has determined the sterility cannot be assured for the affected lot.
Code information: M/N: 00711117; Lot #: 1505956
Distribution pattern: US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Derived failure modes
-
Sterility assurance
sterility cannot be assured