Events

Recall of Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems¿, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA

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
    30641
  • Event Risk Class
    Class 2
  • Event Number
    Z-0340-05
  • Event Initiated Date
    2001-01-25
  • Event Date Posted
    2004-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36256
  • 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
    Cord, Electric, For Endoscope - Product Code FFZ
  • Reason
    An incorrect electrosurgical cord was included in some of the packages.
  • Action
    Consignees were notified by letter sent Federal Express on 01/25/2001.

Device

Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use,...
  • Model / Serial
    Catalog #394236, Lot 3504519
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Singapore
  • Product Description
    Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems¿, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA
  • Manufacturer
    Weck

Manufacturer

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