Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The

FDA device recall Z-0886-2016 · posted 2016-02-25 · Terminated

Recall details

Recalling firm

Teleflex Medical

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FZP

Quantity affected

543 ea.

Distribution

Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium

Date initiated

2016-02-02

Date posted

2016-02-25

Date terminated

2017-08-11

Location

Research Triangle Park, NC

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