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 Recall Z-2327-2016 · Posted None
Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeFZP
Date Initiated2013-08-08
Date Terminated2016-08-15
Product Quantity8,220 ea.
Reason for Recall
The manufacturing and expiration dates are not printed on the blister pack label.
Firm 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.
Root Cause
Error in labeling
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.