FDA Class I recall: ArjoHuntleigh Polska Sara Plus Floor Lift
The FDA has identified ArjoHuntleigh Polska’s Sara Plus Floor Lift this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
• Product Name: ArjoHuntleigh Polska Sara Plus floor lift
• Product Serial Numbers: See recall database entry
• Manufactured Dates: October 13, 2016, to January 13, 2022; Other units that received spare parts (printed circuit board) through March 4, 2022
• Devices Recalled in the U.S.: 1,929 (includes affected spare parts)
• Date Initiated by Firm: April 8, 2022
Device Use
The ArjoHuntleigh Polska Sara Plus is an active floor lift used for short transfers, such as raising patients from bed to a wheelchair or from a wheelchair to a toilet. It is intended for use in hospitals, nursing homes, and other healthcare facilities.
Reason for Recall
ArjoHuntleigh Polska is recalling the Sara Plus floor lift following several complaints of smoke and/or flames coming out of the lift. When the battery is low, the device’s printed circuit board may overheat, leading to smoke or fire. If this situation occurs, anyone using the lift or near it could be injured, including smoke inhalation and/or burns.
There have been 44 complaints about this issue. No injuries or deaths have been associated with the use of this device.
Who May be Affected
• Healthcare personnel who use the Arjo Sara Plus Lift when working with patients.
• People who receive care in a healthcare facility using the Arjo Sara Plus Lift.
What to Do
On April 8, 2022, ArjoHuntleigh Polska issued an Urgent Medical Device Recall letter to all customers who received affected devices, along with a list of potentially affected devices at each facility. The letter’s instructions includes the following guidance for customers in general and healthcare providers/users of the device:
For customers:
• Make sure all care givers and/or users of the Sara Plus floor lift are aware of the issue.
• Locate affected devices by their serial number on the lift behind the rechargeable battery pack or by recognizing the affected devices based on the layout of the device’s display.
• Make a plan for ArjoHuntleigh Polska service technicians to make a product correction for this issue by completing the Customer Response Form attached to the letter and expect Arjo to contact the facility to schedule the free correction.
For healthcare providers/device users:
• Stop use of the Sara Plus lift immediately if smoke appears when using.
• Push Emergency Stop Button.
• Remove the battery from battery socket to prevent any further failure.
The company also offered several precautionary steps for healthcare providers using the lifts:
• Do not leave patients unattended on the lift in any situation.
• Do not use the lift in humid areas or spray the lift’s covers with any liquid. Accidental water ingress can contribute to the printed circuit board failure.
• Do not overload the lift.
• When using the transfer and walking sling for the transfer, the Safe Working Load is 140 kg (308 Ibs).
• When using the same sling for walking practice the Safe Working Load is 190 kg (420 Ibs).
• Do not use the lift with depleted or damaged batteries (over 2 years old) as it may contribute to the printed circuit board damage. Note the manufacturing date of your battery is visible on the battery’s sticker.
• For cleaning, wipe down with a damp cloth using warm water to which a mild detergent has been added. To disinfect the device, clean the equipment first, then wipe it using a solution containing one of the compatible disinfectants. Refer to the Sara Plus Instructions for Use for a detailed guidance.
• Remove the battery from the battery socket on a mast if the lift is unused.
• Make sure that the lift battery is in good working condition before using the lift.
• Charge the battery as soon as battery discharge indicator (small battery symbol) on the lift display falls to three filled segments out of eight.
