FDA Recall Terminated

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

Recall: Z-2327-2016 · Initiated August 8, 2013

Recall

Recall Number
Z-2327-2016
Event Number
74669
Firm
Teleflex Medical
FEI Number
3005747797
Product Code
FZP
Status
Terminated
Root Cause
Error in labeling
Initiated
August 8, 2013
Terminated
August 15, 2016
Address
3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

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

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

Action

Teleflex sent an Urgent Medical Device Recall Notification dated August 8, 2013, to all affected customers. The letter requested that they quarantine the product and to return it to Teleflex. An acknowledgment form was included with the letter which also was to be returned to Teleflex. A separate letter was sent to distributors requesting they conduct a sub-recall. If you have any further questions, please call (610) 378-0131.

Distribution

USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI, and Internationally to Canada

Quantity

8,220 ea.