Events

Recall of Allegiance Laminated Wood Crutches, Youth

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Duro-Med Industries, 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
    29753
  • Event Risk Class
    Class 2
  • Event Number
    Z-1420-04
  • Event Initiated Date
    2004-08-04
  • Event Date Posted
    2004-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34678
  • 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
    Crutch - Product Code IPR
  • Reason
    The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
  • Action
    Duro-Med notified Cardinal Health of the recall by letter dated 8/4/04. Cardinal Health initiated a sub-recall of the products by letter dated 8/18/04. The accounts were informed that the products made in China contain latex, and were requested to check their inventories for the affected products and return those products found to be labeled as 'Made in China' for credit. Questions were directed to Cardinal Quality Systems at 1-800-292-9332.

Device

Allegiance Laminated Wood Crutches, Youth
  • Model / Serial
    catalog #74151-040, all product labeled ''Made in China''
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution through Cardinal Health.
  • Product Description
    Allegiance Laminated Wood Crutches, item 74151-040, Youth - 35'' - 43''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China
  • Manufacturer
    Duro-Med Industries, Inc.

Manufacturer

Duro-Med Industries, Inc.
  • Manufacturer Address
    Duro-Med Industries, Inc., 1788 W Cherry St, P. O. Box 547, Jesup GA 31545-0629
  • Source
    USFDA