Events

Recall of Device Recall DeRoyal

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

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
    39374
  • Event Risk Class
    Class 2
  • Event Number
    Z-1205-2007
  • Event Initiated Date
    2007-07-03
  • Event Date Posted
    2007-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55345
  • 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
    procedure trays - Product Code KDD
  • Reason
    Packaging failure. lack of sterility assurance.
  • Action
    Written notification of the recall was sent (via UPS Ground) beginning 7/03/2007 to consignees to advise them of problem and the recall. The letter stated that the recall was to the User level (which in this case, are the hospitals) and requested return of the product.

Device

Device Recall DeRoyal
  • Model / Serial
    DeRoyal C-Section Tracecart, REF 53-1746.02, Lot 12781158, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal CABG Tracepak, REF 90-2838.11, Lot 12830124, exp 2010-01, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal CABG Tracecart, REF 53-1865.03, Lot 12585413, exp 2008-08, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, Lot 12388751, exp 2009-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Neuro Tracecart, REF 53-1763.02, Lot 12680189, exp 2008-11, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Heart Tracecart, REF 53-1897.02, Lot 12729915, exp 2008-11, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracecart, REF 53-1862.03, Lot 12924403, exp 2010-05, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracepak, REF 90-2774.10, Lot 12493236, exp 2011-09, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Total Knee Tracecart, REF 53-1838.02, Lot 12585296, exp 2009-03, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, Lot 12570676, exp 2008-1105, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Heart Tracecart, REF 53-1725.13, Lot 12617657, exp 2008-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal C-Section Tracecart, REF 53-1837.03, Lot 11829924, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal C-Section Tracecart, REF 53-1781.04, Lot 12866047, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, Lot 12585405, exp 2009-03, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Neuro Tracecart, REF 53-1815.06, Lot 12671151, exp 2008-01, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal AAA Tracecart, REF 53-1765.08, Lot 12862695 exp 2009-04, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracecart, REF 53-1767.08, Lot 12671101, exp 2009-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Assorted non- sterile Tracecarts (with sterile component(s)); || DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Neuro Tracecart, REF 53-1763.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Tracecart, REF 53-1897.02, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracecart, REF 53-1862.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracepak, REF 90-2774.10, non-sterile, Rx only, DeRoyal, Powell, TN 37849; || DeRoyal Total Knee Tracecart, REF 53-1838.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Tracecart, REF 53-1725.13, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Tracecart, REF 53-1837.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Tracecart, REF 53-1781.04, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Neuro Tracecart, REF 53-1815.06, non-sterile, Rx only, DeRoyal, Powell, TN 37849; || DeRoyal AAA Tracecart, REF 53-1765.08, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracecart, REF 53-1767.08, non-sterile, Rx only, DeRoyal, Powell, TN 37849
  • Manufacturer
    DeRoyal Lafollette

Manufacturer

DeRoyal Lafollette
  • Manufacturer Address
    DeRoyal Lafollette, 1501 East Central Ave, La Follette TN 37766
  • Source
    USFDA