Date Initiated by Firm |
August 18, 2009 |
Date Posted |
September 22, 2009 |
Recall Status1 |
Terminated 3 on January 07, 2010 |
Recall Number |
Z-2230-2009 |
Recall Event ID |
52824 |
Product Classification |
Non-AC-powered Patient Lift - Product Code FSA
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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.
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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 IL 60101-6183
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For Additional Information Contact |
Ms. Traci Giovenco 800-323-1245
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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.
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FDA Determined Cause 2 |
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
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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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