FDA Enforcement
Class II
Terminated
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Recall: Z-0001-2016
·
Reported October 7, 2015
Enforcement
- Recall Number
- Z-0001-2016
- Event ID
- 71987
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- US Endoscopy Group Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 7, 2015
- Initiation Date
- July 14, 2015
- Classification Date
- October 1, 2015
- Termination Date
- October 27, 2016
- Address
- 5976 Heisley Rd, N/A, Mentor, OH, 44060-1873, United States
Description
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Reason
The company has determined the sterility cannot be assured for the affected lot.
Code Info
M/N: 00711117; Lot #: 1505956
Distribution
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Quantity
41 units