News & Events
This press release, issued March 4, 2004, was modified Nov. 23, 2004, to correct errors with the names of certain parts of the patient lifts. The corrections were made to paragraphs three and six.
FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
March 4, 2004
Media Inquiries: 301-827-6242
FDA Announces Nationwide Recall of Faulty Patients Lifts
The Food and Drug Administration (FDA) today announced that Moving Solutions, Inc., of Downers Grove, Ill., is recalling its patient lifts because of a faulty design.
Patient lifts are mechanical sling-like devices used to lift and move patients from one place to another, as from a bed to a bath. They are used in hospitals and nursing homes in the care of elderly and handicapped persons. Some may also be used in homes.
With the Moving Solutions lift, excessive wear of the hanger bar bolt, which secures the hanger bar to the lift arm, of the patient lift, will cause the bolt to break. When the bolt breaks, the hanger bar is no longer secured to the lift arm, which will cause the patient to fall. The hanger bar may also fall on the patient, which could result in serious injury, even death.
Facilities should stop using these lifts until the problem is corrected.
FDA has received one report of death related to the failure of the bolt.
The recall involves all FAABORG model battery operated patient lifts distributed by Moving Solutions, because the hanger bar is interchangeable between all models of FAABORG patient lifts. Some 856 lifts have been distributed throughout the United States.
FAABORG, located in Denmark, is the manufacturer. Moving Solutions is the initial U.S. distributor; however there may be some other distributors.
Moving Solutions notified user facilities of a problem with the device in November 2001. In a letter, they directed facilities to perform maintenance and check the hanger bar bolt for any signs of wear.
The firm again notified user facilities on Jan. 21, 2004 about a continuing problem with the bolt and included a nylon washer with their letter, instructing facilities to insert the washer between the hanger bar bolt and the sling spreader arm. The FDA has no assurance that the washer will prevent the rubbing that caused the bolt to wear and break, and an investigation is underway.
FDA is monitoring the firm's action, which constitutes a Class I recall, to make sure that all facilities which use these lifts are adequately notified of the problem and to make sure that no more products are distributed.
A class I recall is the most serious type of recall. It is a situation in which there is a reasonable probability that use of the product will cause serious injury or death.