Events

Recall of Device Recall Auto Endo5 Hemolok Automatic Clip Applier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73181
  • Event Risk Class
    Class 2
  • Event Number
    Z-0886-2016
  • Event Initiated Date
    2016-02-02
  • Event Date Posted
    2016-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143353
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Clip, implantable - Product Code FZP
  • 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.
  • 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

Device

Device Recall Auto Endo5 Hemolok Automatic Clip Applier
  • Model / Serial
    73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
  • Product 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.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA