FDAFDA · Food and drugs·Recall number Z-0006-2013
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.
Published October 10, 2012 · Recall initiated: November 14, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Endoscopy Group Inc
- Distributor
- 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.
- Lot
- Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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