—#148156

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

FDA product code: FZP — Clip, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K982313
Affected lot / code info: Lot/Serial Number 01J1200435

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2013-08-08
Terminated: 2016-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148156. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.