Medical Device Recall: Z-0006-2013

FDA Recalls dataset · Firm: US Endoscopy Group Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-11-14 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0006-2013.

Recall Res Number
Z-0006-2013
Recalling Firm / Manufacturer
FEI Number
1000122656
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-11-14
Date Posted
2012-10-03
Date Terminated
2013-07-02
Product Code
FGO
Event Number
63196
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.

Action Details 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.

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

Related Establishments / Registrations

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