Recall Z-1416-2017 ยท GCJ Laparoscope, General & Plastic Surgery
US Endoscopy Group Inc
Roth Net Polyp Retrieval
| Date | Mar 8, 2017 (initiated Dec 13, 2016) |
| Status | Terminated |
| Reason | The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration. |
| Root cause | Labeling mix-ups |
| Action | US Endoscopy Group sent an Urgent: Roth Net Polyp Retriever Recall letter dated January 6, 2017, to all affected customers. The firm requested their customers to do the following: 1. Quarantine and destroy the affected Roth Net devices in your inventory. 2. Contact US Endoscopy Customer Service at 1-800-769-8226 to obtain no cost replacement product. 3. Complete and return the attached Response Card. For further information please call (440) 358-6055. |
| Quantity | 2,131 units |
| Distribution | US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122462 | ROTH NET RETRIEVER United States Endoscopy Group, Inc., Sep 11, 2012 |