Recall Z-0160-2009 ยท FZP Clip, Implantable
Telefelx Medical
WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner a
| Date | Sep 16, 2008 (initiated Aug 22, 2008) |
| Status | Terminated |
| Reason | A hole in the sterile unit blister pack was detected that would compromise sterility. |
| Root cause | Packaging process control |
| Action | Consignees were notified via UPS next day on/about August 22, 2008. They were instructed to cease use and distribution and quarantine all affected product immediately. If they have any of the affected product they were instructed to return all it to Teleflex Medical via provided UPS-Ground. An Acknowledgement form was provided to be completed and returned via fax to Teleflex Medical to confirm receipt of the notification and amount of product on hand for return. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first maili |
| Quantity | 786036 (total pieces) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021808 | WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER Weck, Aug 14, 2002 |