Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle,
FDA device recall Z-0771-2014 · posted 2014-01-15 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Sterility cannot be guaranteed.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 17,450 ea
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-12-19
- Date posted
- 2014-01-15
- Date terminated
- 2016-05-20
- Location
- Research Triangle Park, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECTRO-CAUTERY SUCTION TUBE (K881413) | Alto Development Corp. | 1988-04-21 |