Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medi...

FDA Recall #Z-0770-2014 — Class II — December 19, 2013

Recall #Z-0770-2014 Date: December 19, 2013 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

Sterility cannot be guaranteed.

Recalling Firm

Teleflex Medical — Research Triangle Park, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

17,450 ea.

Distribution

Nationwide Distribution.

Code Information

Catalog Number: 809600, Lot Numbers: 01M1000201, 01A1100320, 01C1000012, 01C1000385, 01E1000392.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated