Events

Recall of Device Recall Mattress Model 5185 and 5185XL 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
    56335
  • Event Risk Class
    Class 2
  • Event Number
    Z-2403-2010
  • Event Initiated Date
    2007-08-29
  • Event Date Posted
    2010-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93265
  • 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 september 2007 invacare corporation recalled the innerspring mattresses associated with invacare's ivc bed series full electric beds, semi-electric beds and manual beds and the valuecare bed series semi electric bed. these mattresses were manufactured between june 28, 2007 and july 12, 2007. these mattresses when used in combination with the ivc and valuecare series of manual, semi-electric a.
  • Action
    Consignees of the product were notified by letter dated 09/05/2007. Consignees were instructed to destroy the affected mattresses and to return the completed confirmation of the destruction form to Invacare.

Device

Device Recall Mattress Model 5185 and 5185XL used with IVC and ValueCare Series Beds
  • Model / Serial
    Model 5185 and 5185XL
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Mattress Model 5185 and 5185XL. || Manufactured by: || Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. || Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.
  • 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