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U.S. Department of Health and Human Services

Class 2 Device Recall Auto Endo5 Hemolok Automatic Clip Applier

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  Class 2 Device Recall Auto Endo5 Hemolok Automatic Clip Applier see related information
Date Initiated by Firm February 02, 2016
Date Posted February 25, 2016
Recall Status1 Terminated 3 on August 11, 2017
Recall Number Z-0886-2016
Recall Event ID 73181
510(K)Number K142777  
Product Classification Clip, implantable - Product Code FZP
Product 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.
Code Information 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Tara Torres-Heckman
610-378-0131
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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 recalls@teleflex.com. This will document receipt of the letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Quantity in Commerce 543 ea.
Distribution Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = Teleflex Medical, Inc.
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