Z-1453-2015 Class II Terminated
FDA device recall Z-1453-2015 was initiated by US Endoscopy Group Inc on March 10, 2015 and is designated Class II. Reason for recall: A wire component on the distal grasping assembly of the device became detached.. The recall status is terminated (terminated October 27, 2016). Affected quantity: 1695 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2015
- Initiation Date
- March 10, 2015
- Termination Date
- October 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1695 units
Product Description
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.
Reason for Recall
A wire component on the distal grasping assembly of the device became detached..
Distribution Pattern
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, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.
Code Information
Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.