Recall Z-0826-2015— Teleflex Medical

Name: FDA recall Z-0826-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-03

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-12-03, terminated 2017-11-24. It names one FDA 510(k) clearance: K800079. Product: WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.. Reason: The manufacturing dates and expiration dates were transposed on the Tyvek label..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Terminated: 2017-11-24
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K800079 — HEMOCLIP SURGICAL OCCLUDING CLIPEdward Weck, Inc.·cleared 1980-01-28

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 Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.

Reason for recall

The manufacturing dates and expiration dates were transposed on the Tyvek label.

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