Recall Z-1542-2014— Med-Mizer, Inc.
Class II · Terminated
Class II FDA medical device recall by Med-Mizer, Inc., initiated 2014-04-18, terminated 2016-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.. 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 th.
- Recalling firm
- Med-Mizer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-18
- Terminated
- 2016-05-23
- Firm location
- Batesville, IN, United States
Product description
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
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 th
Data sourced from openFDA. This site is unofficial and independent of the FDA.