Recall Z-2327-2016— Teleflex Medical

Name: FDA recall Z-2327-2016
Creator: U.S. Food and Drug Administration
Published: 2013-08-08

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2013-08-08, terminated 2016-08-15. It names one FDA 510(k) clearance: K982313. Product: Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. Reason: The manufacturing and expiration dates are not printed on the blister pack label..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2013-08-08
Terminated: 2016-08-15
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K982313 — HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPSWeck Closure Systems·cleared 1998-08-10

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

Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable

Reason for recall

The manufacturing and expiration dates are not printed on the blister pack label.

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