FDA Recall Terminated

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.

Recall: Z-2230-2009 · Initiated August 18, 2009

Recall

Recall Number
Z-2230-2009
Event Number
52824
Firm
ArjoHuntleigh
FEI Number
3007515958
Product Code
FSA
Status
Terminated
Root Cause
Manufacturing material removal
Initiated
August 18, 2009
Posted
September 22, 2009
Terminated
January 7, 2010
Address
2349 W Lake St, Addison, IL, 60101-6183

Description

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.

Reason

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.

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.

Distribution

Worldwide Distribution

Quantity

214 units