Events

Recall of Weck, Endo5, Hem-o-lok¿ ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems¿, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.

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

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
    30640
  • Event Risk Class
    Class 3
  • Event Number
    Z-0393-05
  • Event Initiated Date
    2001-10-31
  • Event Date Posted
    2005-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36255
  • 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
    Applier, Surgical, Clip - Product Code GDO
  • Reason
    The flush port on some appliers was occluded with an epoxy resin during manufacturing.
  • Action
    Consignees were notified by letter on 10/31/2001.

Device

Weck, Endo5, Hem-o-lok¿ ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean a...
  • Model / Serial
    Catalog #544965, Lot #694505 & 694506
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.
  • Product Description
    Weck, Endo5, Hem-o-lok¿ ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems¿, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
  • Manufacturer
    Weck

Manufacturer

Weck
  • Manufacturer Address
    Weck, 1 Weck Dr., Research Triangle Park NC 27709
  • Source
    USFDA