Class 1 Device Recall Alenti Lift Hygiene Chair

• Date Initiated by Firm: June 08, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on December 13, 2004
• Recall Number: Z-1046-04
• Recall Event ID: 29137
• Product Classification: Lift, Patient, Non-Ac-Powered - Product Code FSA
• Product: Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers CDB8003-01-US and CDB8053-01-US (with scale)
• Code Information: model numbers CDB8003-01-US and CDB8053-01-US, all serial numbers
• FEI Number: 1419652
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Brenda Ammonette; 800-323-1245
• Manufacturer Reason for Recall: There has been an increased number of tipping incidents and subsequent patient injuries.
• FDA Determined Cause: Other
• Action: Safety Advice Notice letters dated 6/8/04 were sent by certified mail to the end users, informing them of the possibility of tipping if the Alenti catches on other equipment; if the resident is not positioned correctly on the chair; if the Alenti is used with an inappropriate resident; if the resident is left unattended, particularly when the Alenti is in an elevated position; and if the safety belt is not used as a positioning belt. The end users were provided with a laminated hang tag to place on the lift with the listed safety aspects and warnings, a copy of the revised Alenti Operating and Product Care Instructions dated April 2004, and an Alenti safety belt for each of their lifts. The users were requested to complete enclosed customer response form indicating that they received and understood the safety advice notice, that they received the revised manual and destroyed all previous copies of the manual, that they received a safety belt for each lift, and that they made the patient lift operators aware of the safety advice notice and that they understood its contents. Any questions were directed to the Quality Assurance Department, at 1-800-323-1245, ext. 6103. Revised hang tags including instructions to check the castors on the lift to assure that they are secured and functioning properly, as well as providing the operating instructions for the safety belts, were sent to the accounts on 7/13/04.
• Quantity in Commerce: 1,035 units
• Distribution: Nationwide and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.