Medical device recalls Moderate risk

US Endoscopy Group Inc recalls Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi…

Recall date
March 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1453-2015
FDA classification
Class II
Brand / firm
US Endoscopy Group Inc
Sold / distributed
Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CANA…

Why it was recalled

A wire component on the distal grasping assembly of the device became detached..

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

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