Events

Recall of CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds

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

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
    56336
  • Event Risk Class
    Class 2
  • Event Number
    Z-2402-2010
  • Event Initiated Date
    2007-10-11
  • Event Date Posted
    2010-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93266
  • 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
    Cover, Mattress (Medical Purposes) - Product Code FMW
  • Reason
    In october 2007 invacare corporation, florida recalled careguard mattresses, models cg10180 and cg10180a, associated with ivc bed series full electric beds, semi-electric beds and manual beds and the valuecare bed series semi electric beds, when used with invacare bed rails. affected bed packages are bed24ivc, bed25ivc, bed24ca, and bed25ca. the mattresses when used in combination with the ivc a.
  • Action
    Consignees were notified of the recall by letter dated October 15, 2007 and entitled "CareGuard Mattresses Provided Since September 2006 In combination with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds, and the Value Care Bed Series Semi Electric Bed, and Full and Half-Length Rails". Depending on the mattress usage the consignees were instructed to either: A: 1) Move the bed rail cross bar from the 5th and 6th spring location on the head section of the bed to the 6th and 7th spring location on the head section of the bed in accordance with the enclosed instructions and document your actions on the enclosed tracking sheet. 2) Return of the Product Tracking Report indicating disposition of the recalled product and acknowledgement of receipt of the recall package. 3) The tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credit. or B) 1) contact Customer Service and request part No. 6022, which is a kit that contains a 2" convoluted foam pad, warning label and installation instructions. Testing has shown that the addition of the foam pad on a new mattress with Invacare half rails / bed combination meets the Guidance requirements." 2) When you have completed placing the label and foam topper on all of your affected mattresses, return the tracking sheet to us and we will credit your account $10 for each mattress you have listed. the tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credi

Device

CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds
  • Model / Serial
    September 2006 through July 2007.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. || Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). || Manufactured by: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. || Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 2101 E. Lake Mary Blvd., Sanford FL 32773
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA