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U.S. Department of Health and Human Services

Class 2 Device Recall SS Retratabed, Clinical Contour

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 Class 2 Device Recall SS Retratabed, Clinical Contoursee related information
Date Initiated by FirmApril 18, 2014
Date PostedMay 02, 2014
Recall Status1 Terminated 3 on May 23, 2016
Recall NumberZ-1543-2014
Recall Event ID 67871
Product Classification Bed, hydraulic, adjustable hospital - Product Code FNK
ProductRetractaBed , 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.
Code Information Model 801 : 50000-50018; Model 802n : 600000-600789 Model 803: 500000-500342; 803A 700000-701724 
Recalling Firm/
Manufacturer		 Med-Mizer, Inc.
80 Commerce Dr
Batesville IN 47006-6700
For Additional Information ContactTed M. Tekulve
812-932-2345
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Process change control
ActionOn 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.
Quantity in Commerce2980
DistributionUSA (nationwide)
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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