Events

Recall of Device Recall DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal 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
    67686
  • Event Risk Class
    Class 2
  • Event Number
    Z-1210-2014
  • Event Initiated Date
    2014-02-21
  • Event Date Posted
    2014-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126065
  • 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
    Restraint, protective - Product Code FMQ
  • Reason
    Moldy smell in product.
  • Action
    DeRoyal initiated an Urgent Voluntary Recall dated February 21, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. DeRoyal has asked that products be destroyed, and that notice of destruction be sent back. For questions contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.

Device

Device Recall DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017,
  • Model / Serial
    lot numbers 1143442 and 1161762
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
  • Product Description
    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 || Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA