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Press Release from Arjo, Inc. Regarding Recall of Arjo MINSTREL Patient Lifts

The following press release is from Arjo, Inc. relating to a Class I Medical Device Recall.

For Immediate Release:

May 26, 2004

ARJO, INC Announces a Nationwide, Voluntarily Recall of the MINSTREL Patient Lifts

Contact:
Arjo, Inc.
Quality Assurance Department
1.800.323.1245, ext. 6140 or 6103

Arjo, Inc. today announced that it is voluntarily conducting a Class I recall for two models, HMB001-US (with out scale) and HMB002-US (with scale) of its MINSTREL Patient Lifts because of mechanical problems that could result in serious patient injury. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of the product will cause serious adverse health consequences or death.

Arjo is aware of reports of the hanger bar falling off the lift, causing the patient to fall and be injured. One of these incidents resulted in death.

This recall involves 116 MINSTREL Patient Lifts that could possibly result in hanger bar detachment due to pin migration or pin breakage in the hanger bar assembly. No other Arjo, Inc. devices are involved in this action.

All affected customers were formally notified via certified mail of the MINSTREL Field Correction/Recall on April 30, 2004. Affected customers have already been advised to exercise the option of inspecting their MINSTREL Patient Lift and completing an Inspection Form or removing their MINSTREL Patient Lift from use pending repair from an authorized Arjo Service Technician. Affected customers have also been advised to complete a Customer Response Form and return it to Arjo, Inc. Quality Assurance Department.

Appropriate corrective action was taken to eliminate the MINSTREL problem and 100 units have already been repaired. The remaining 16 MINSTREL Lifts will be repaired by May 28, 2004.

Arjo, Inc. is voluntarily cooperating with the Food and Drug Administration to ensure that all affected customers are notified of this issue. Arjo, Inc. formally notified the Food and Drug Administration on April 28, 2004.

Arjo, as a global leader in patient lifts, is committed to ongoing product surveillance to assure product safety and reliability.

Any inquiries regarding this action should be directed to the Quality Assurance Department using the above referenced toll-free number.

Updated May 27, 2004

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