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
This recall has been terminated (originally issued August 8, 2013).
- Company
- Teleflex Medical
- Recall Initiated
- August 8, 2013
- Terminated
- August 15, 2016
- Recall Number
- Z-2327-2016
- Quantity
- 8,220 ea.
- Firm Location
- Morrisville, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The manufacturing and expiration dates are not printed on the blister pack label.
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
Lot / Code Info
Lot/Serial Number 01J1200435
Root Cause
Error in labeling
Action Taken
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.