Home / Recalls / US Endoscopy Group Inc / Z-1011-2019

Z-1011-2019 Class II Terminated

Recalled by US Endoscopy Group Inc — Mentor, OH

Recall Details

Product Type
Devices
Report Date
March 20, 2019
Initiation Date
February 4, 2019
Termination Date
August 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
483 units ( 325 units US and 158 OUS)

Product Description

US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

Reason for Recall

Potential esophageal laceration during a patient procedure

Distribution Pattern

Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.

Code Information

Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.

Other recalls by US Endoscopy Group Inc

  • 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-0001-2016 Class II — Histolock Resection Device, US Endoscopy. An electrosurgical device designed (July 14, 2015)
  • 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)