Recall Z-2327-2016
Teleflex Medical · initiated August 8, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot/Serial Number 01J1200435
Reason for recall
The manufacturing and expiration dates are not printed on the blister pack label.
FDA-determined 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.
Details
- Recall number
- Z-2327-2016
- Initiated
- August 8, 2013
- Terminated
- August 15, 2016
- Product code
- FZP – Clip, Implantable
- Quantity
- 8,220 ea.
- 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
- Recalling firm
- Teleflex Medical, Morrisville, NC