Recall Z-0886-2016 ยท FZP Clip, Implantable
Teleflex Medical
Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use i
| Date | Feb 25, 2016 (initiated Feb 2, 2016) |
| Status | Terminated |
| Reason | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application. |
| Root cause | Nonconforming Material/Component |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter dated February 2, 2016 to customers. The letter identified the affected product, problem and actions to be taken. A separate letter was sent to distributors advising them to conduct a sub-recall. Customers were instructed to: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed in the letter. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1- 855-419-8507, Attn: Customer Service or email to recalls@teleflex.com.This will |
| Quantity | 543 ea. |
| Distribution | Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier Teleflexmedical, Inc., Dec 19, 2014 |