Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2230-2009

Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo...

Arjohuntleigh AB / initiated 2009-08-18 / Terminated / root cause: manufacturing process

ArjoHuntleigh began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2230-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjohuntleigh AB
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.
Product code
FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag
manufacturing process
FDA root cause
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
Product codes and lots
all six digit serial numbers beginning with 6xxxxx and all serial numbers 08xxxxxxxx up to 0812001186.