Recall Z-2327-2016 ยท FZP Clip, Implantable
Teleflex Medical
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
| Date | Aug 8, 2013 |
| Status | Terminated |
| Reason | The manufacturing and expiration dates are not printed on the blister pack label. |
| Root cause | Error in labeling |
| 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982313 | HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS Weck Closure Systems, Aug 10, 1998 |