Class 1 Recall: Arjo MINSTREL Patient LiftsApr 30, 2004 | ww.fda.gov
April 30, 2004
MINSTREL Patient Lifts, models HMB001-US (without scale) and HMB002-US (with scale).
Use: The device is a battery powered patient lift. Patient lifts are intended to be used to lift and transport patients from one location to another, such as from a bed to a bath.
50 North Gary Avenue
Roselle, IL 60172
Reason for Recall:
There are two mechanical problems for which the MINSTREL patient lift is currently being recalled. The first involves the hanger bar detaching from the lift resulting in the patient falling to the ground because of a missing spring washer. The second problem involves a bolt in the foot pedal assembly becoming loose which allows the foot pedal assembly to fall off of the lift. This results in the lift becoming unstable and the patient possibly falling.
Ms. Brenda Ammonette
Quality Assurance Manager
Facilities should either inspect their MINSTREL lifts and follow the instructions in the MINSTREL Field Correction/Recall letter sent to all facilities or they should take the lifts out of service until they can be inspected by an Arjo service engineer. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
For additional information on this product recall, see the Arjo Inc. press release at: http://www.fda.gov/cdrh/recalls/recall-043004-pressrelease.html or call Arjo Inc. at 1-800-323-1245, ext. 6140 or 6103.
Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00850.html. Scroll down to "Recalls and Field Corrections: Devices – Class I".