Device product
Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
Z-0770-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,450 ea.
- Official record key
device-enforcement:Z-0770-2014
Official wording
Reason: Sterility cannot be guaranteed.
Code information: Catalog Number: 809600, Lot Numbers: 01M1000201, 01A1100320, 01C1000012, 01C1000385, 01E1000392.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Sterility assurance
Sterility cannot be guaranteed