Recall Z-0771-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Teleflex Medical
Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
| Date | Jan 15, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | Sterility cannot be guaranteed. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified via letter on 12/19/2013. They were instructed to, immediately discontinue use and quarantine any products with the catalog numbers listed above. Consignees are to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. If they have no affected stock, they were to complete the enclosed Recall Acknowledgment Form and fax it to Teleflex Medical Customer Service. Distributors were instructed to communicate this recall to any of their customers who have received product. |
| Quantity | 17,450 ea |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881413 | ELECTRO-CAUTERY SUCTION TUBE Alto Development Corp., Apr 21, 1988 |