Home / Recalls / US Endoscopy Group Inc / Z-0001-2016

Z-0001-2016 Class II Terminated

Recalled by US Endoscopy Group Inc — Mentor, OH

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

Other recalls by US Endoscopy Group Inc

  • Z-1011-2019 Class II — US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Cl (February 4, 2019)
  • Z-1416-2017 Class III — Roth Net Polyp Retrieval (December 13, 2016)
  • Z-0289-2017 Class II — Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 (May 18, 2016)
  • Z-1453-2015 Class II — Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodi (March 10, 2015)
  • Z-1943-2015 Class II — Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Vel (February 17, 2015)
  • Z-0861-2015 Class II — UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary pack (October 31, 2014)
  • Z-1099-2013 Class II — Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (March 7, 2013)
  • Z-2396-2012 Class II — Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., (December 22, 2011)
  • Z-0006-2013 Class II — Endoscopic retrieval device. The disposable Raptor grasping device in intende (November 14, 2011)