Recalls / —
—#124748
Product
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.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K881413
- Affected lot / code info
- Catalog Number: 809610, Lot Number: 01A1100610.
Why it was recalled
Sterility cannot be guaranteed.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 2917 Weck Dr., Research Triangle Park, North Carolina 27709
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2013-12-19
- Posted by FDA
- 2014-01-15
- Terminated
- 2016-05-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.