Recall Z-0771-2014— Teleflex Medical

Name: FDA recall Z-0771-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-19

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2013-12-19, terminated 2016-05-20. It names one FDA 510(k) clearance: K881413. 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.. Reason: Sterility cannot be guaranteed..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Terminated: 2016-05-20
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K881413 — ELECTRO-CAUTERY SUCTION TUBEAlto Development Corp.·cleared 1988-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Sterility cannot be guaranteed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.