Class 2 Device Recall Raptor

• Date Initiated by Firm: November 14, 2011
• Date Posted: October 03, 2012
• Recall Status: Terminated 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
• FEI Number: 1000122656
• 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: 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