Events

Recall of Weck Hemoclip Plus Ligating Clips

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
    29820
  • Event Risk Class
    Class 2
  • Event Number
    Z-1392-04
  • Event Initiated Date
    2003-10-24
  • Event Date Posted
    2004-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34593
  • 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, Hemostatic Clip - Product Code HBT
  • Reason
    Hole in the sterile unit blister pack that could compromise sterility.
  • Action
    The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.

Device

Weck Hemoclip Plus Ligating Clips
  • Model / Serial
    All lots manufactured between 2001-8 through 2002-12 for all three products and lots 738967, 763871 and 714124 for 25 Small Titanium Clips; lots 703251, 722666 and 825952 for 10 Large Titanium Clips and lots 738966, 754641 and 824238 for 25 Medium Titanium Clips
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
  • Product Description
    Ref. No. 533735 and 534735 Hemoclip Plus, 25 Small Titanium Clips, Cartridge; Ref. No. 533870 Hemoclip Plus, 10 Large Titanium Clips/Cartridge and Ref. No. 533700 Hemoclip Plus, 25 Medium Titanium Clips/Cartridge
  • Manufacturer
    Weck

Manufacturer

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