Events

Recall of SS Retratabed, Clinical Contour

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med-Mizer, 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
    67871
  • Event Risk Class
    Class 2
  • Event Number
    Z-1543-2014
  • Event Initiated Date
    2014-04-18
  • Event Date Posted
    2014-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126777
  • 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
    Bed, hydraulic, adjustable hospital - Product Code FNK
  • Reason
    All configurations of the ss retractabed, clinical contour, made prior to june 7, 2008 may have had insufficient welding on the foot cross tube. this tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. if the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on t.
  • Action
    On 5/1/14, Med-Mizer sent URGENT: MEDICAL DEVICE RECALL notification to their consignees. Notification included description of the affected product, reason for recall, risk to health, instructions on how to recognize how the device may fail, and instructions for actions to be completed by their consignees. Contact Information: 1-877-867-7365, sales@med-mizer.com, 8am-5pm EST.

Device

SS Retratabed, Clinical Contour
  • Model / Serial
    Model 801 : 50000-50018; Model 802n : 600000-600789 Model 803: 500000-500342; 803A 700000-701724
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide)
  • Product Description
    RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour || 120 V, ...Max Safe Working Load 450 LBS. || Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
  • Manufacturer
    Med-Mizer, Inc.

Manufacturer

Med-Mizer, Inc.
  • Manufacturer Address
    Med-Mizer, Inc., 80 Commerce Dr, Batesville IN 47006-6700
  • Manufacturer Parent Company (2017)
    Med-Mizer Inc
  • Source
    USFDA