Class 2 Device Recall ARJO, Carendo MultiPurpose Hygiene Chair

• Date Initiated by Firm: October 15, 2007
• Date Posted: December 01, 2007
• Recall Status: Terminated on July 27, 2009
• Recall Number: Z-0261-2008
• Recall Event ID: 45402
• Product Classification: Hygiene Chair - Product Code FSA
• Product: ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden
• Code Information: Model BIB2003-01, All Serial Numbers
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Traci Giovenco; 630-307-2756
• Manufacturer Reason for Recall: Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
• FDA Determined Cause: Device Design
• Action: Arjo sent Customer Field Correction Notification letters dated 10/15/07 to the end user accounts who received the affected chairs, advising them of the potential for the pinching of male patient genitals between moving parts of the care raiser function of the Carendo Hygiene Chair. They were instructed to review the enclosed revised Operating and Product Care Instructions manual, highlighting the warnings on pages 18 and 20; ensure all users receive refresher training in the chair's proper use and have access to the revised manual; and complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter. Any questions were directed to the Arjo Quality Department at 800-323-1245, ext. 6140 or 6165.
• Quantity in Commerce: 1,342 hygiene chairs
• Distribution: Nationwide
• 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.