Z-0001-2016 Class II Terminated
FDA device recall Z-0001-2016 was initiated by US Endoscopy Group Inc on July 14, 2015 and is designated Class II. Reason for recall: The company has determined the sterility cannot be assured for the affected lot. The recall status is terminated (terminated October 27, 2016). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2015
- Initiation Date
- July 14, 2015
- Termination Date
- October 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product 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 for Recall
The company has determined the sterility cannot be assured for the affected lot.
Distribution Pattern
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Code Information
M/N: 00711117; Lot #: 1505956