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U.S. Department of Health and Human Services

Class 2 Device Recall Raptor

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  Class 2 Device Recall Raptor see related information
Date Initiated by Firm November 14, 2011
Date Posted October 03, 2012
Recall Status1 Terminated 3 on July 02, 2013
Recall Number Z-0006-2013
Recall Event ID 63196
510(K)Number K962676  
Product Classification Dislodger, stone, flexible - Product Code FGO
Product 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.
Code Information Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Craig L. Moore
440-639-4494 Ext. 378
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action US Endoscopy initiated a Voluntary Product Recall letter initiated November 11, 2011. The letter identified the product the problem and the action needed to be taken by the customer. US Endoscopy will provide a free replacement or grant your facility a credit toward a future purchase for every device that is returned to US Endoscopy or verified as having been used or destroyed. For further questions please call 440-639-4494 ext. 378.
Quantity in Commerce 1153
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGO and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.
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