Recall Z-0006-2013 ยท FGO Dislodger, Stone, Flexible
US Endoscopy Group Inc
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.
| Date | Oct 3, 2012 (initiated Nov 14, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE United States Endoscopy Group, Inc., Oct 4, 1996 |