Recall Z-2759-2016 ยท GDO Applier, Surgical, Clip
Teleflex Medical
WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge fo
| Date | Sep 8, 2016 (initiated Aug 24, 2016) |
| Status | Terminated |
| Reason | Misbranded: Incorrect etching on the device. |
| Root cause | Error in labeling |
| Action | Teleflex sent an Urgent Medical Device Notification letter dated August 24, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. For questionscontact your local sales representative or Customer Service at 1-866-246-6990. |
| Quantity | 49 units |
| Distribution | Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.