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 in procedures involving ligation of vessels or tissue structures.
Recall
- Recall Number
- Z-0886-2016
- Event Number
- 73181
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- FZP
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 2, 2016
- Posted
- February 25, 2016
- Terminated
- August 11, 2017
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186
Description
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 in procedures involving ligation of vessels or tissue structures.
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.
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 [email protected] will document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will document receipt of the letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
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