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Z-0006-2013 Class II Terminated

Recalled by US Endoscopy Group Inc — Mentor, OH

FDA device recall Z-0006-2013 was initiated by US Endoscopy Group Inc on November 14, 2011 and is designated Class II. 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 … The recall status is terminated (terminated July 2, 2013). Affected quantity: 1153.

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

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