Events

Recall of Device Recall RICHARD WOLF TUBE SET FOR TEM

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

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
    79886
  • Event Risk Class
    Class 2
  • Event Number
    Z-1868-2018
  • Event Initiated Date
    2018-03-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163812
  • 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
    Insufflator, laparoscopic - Product Code HIF
  • Reason
    Tube ends may be mixed up.
  • Action
    The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to marek.rast@richard-wolf.com.

Device

Device Recall RICHARD WOLF TUBE SET FOR TEM
  • Model / Serial
    Lot numbers: 32062417, 32133317
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. || Used for the transanal endoscopic microsurgery.
  • Manufacturer
    Richard Wolf GmbH

Manufacturer

Richard Wolf GmbH