Events

Recall of Device Recall Scanlan MobinUddin Vein Holder

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

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
    37596
  • Event Risk Class
    Class 2
  • Event Number
    Z-0701-2007
  • Event Initiated Date
    2007-02-19
  • Event Date Posted
    2007-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50950
  • 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
    Vein Holder - Product Code KDC
  • Reason
    Incorrectly assembled by manufacturer.
  • Action
    The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered.

Device

Device Recall Scanlan MobinUddin Vein Holder
  • Model / Serial
    Lot AZ115806.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA including states of IN, MO and country of Japan
  • Product Description
    SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.
  • Manufacturer
    Scanlan International Inc

Manufacturer

Scanlan International Inc
  • Manufacturer Address
    Scanlan International Inc, 1 Scanlan Plz, Saint Paul MN 55107-1639
  • Source
    USFDA