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U.S. Department of Health and Human Services

Class 2 Device Recall Maxi Move Scoop Stretcher

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 Class 2 Recall
Maxi Move Scoop Stretcher
see related information
Date Posted September 22, 2009
Recall Status1 Terminated on January 07, 2010
Recall Number Z-2230-2009
Recall Event ID 52824
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.
Code Information all six digit serial numbers beginning with 6xxxxx and all serial numbers 08xxxxxxxx up to 0812001186.
Recalling Firm/
Manufacturer
ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall
A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for positioning.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Manufacturing Material Removal
Action ArjoHuntleigh sent their customers a cover letter and the Field Safety Notification, informing them of the potential problem with the safety latches on the stretcher and a pending visit from an ArjoHuntleigh Service Technician to correct the problem. These letters were sent via UPS 2nd day delivery on 8/18/09. The customers were requested to test their stretchers upon receipt of the letter following the instructions for checking the safety latches on the stretcher: * Place the stretcher on its side on a non-scratch surface. * Try to pull the two sides apart with the safety latch engaged. * Test both the head and foot ends of the stretcher. * If the stretcher pulls apart, remove it from use immediately. It is important to note that all affected stretchers will be upgraded, whether they fail the test or not.
Quantity in Commerce 214 units
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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