Device 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.
Z-0771-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,450 ea
- Official record key
device-enforcement:Z-0771-2014
Official wording
Reason: Sterility cannot be guaranteed.
Code information: Catalog Number: 809610, Lot Number: 01A1100610.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Sterility assurance
Sterility cannot be guaranteed