Z-1453-2015Class II
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones...
United States Endoscopy Group, Inc. / initiated 2015-03-10 / Terminated
US Endoscopy Group Inc began a recall of Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the... on . FDA classified it as Class II and gives the reason as "A wire component on the distal grasping assembly of the device became detached". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1453-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- United States Endoscopy Group, Inc.
- Product
- 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.
- Product code
- OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
- Reason for recall
- A wire component on the distal grasping assembly of the device became detached..
- FDA root cause
- Under Investigation by firm
- Action
- On 03/25/2015 the firm sent recall notification letters to their customers via email.
- Quantity in commerce
- 1695 units
- Distribution
- 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.
- Product codes and lots
- Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1453-2015 | Class II | Terminated | Voluntary: Firm initiated |
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