Home / Recalls / US Endoscopy Group Inc / Z-0006-2013

Z-0006-2013 Class II Terminated

Recalled by US Endoscopy Group Inc — Mentor, OH

Recall Details

Product Type
Devices
Report Date
October 10, 2012
Initiation Date
November 14, 2011
Termination Date
July 2, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1153

Product Description

Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

Reason for Recall

When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.

Code Information

Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238

Other recalls by US Endoscopy Group Inc

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  • 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)