Recall Z-0826-2015 ยท FZP Clip, Implantable
Teleflex Medical
WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
| Date | Dec 17, 2014 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | The manufacturing dates and expiration dates were transposed on the Tyvek label. |
| Root cause | Labeling Change Control |
| Action | Consignees were notified by letter on 12/03/2014. |
| Quantity | 3180 units |
| Distribution | US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800079 | HEMOCLIP SURGICAL OCCLUDING CLIP Edward Weck, Inc., Jan 28, 1980 |