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U.S. Department of Health and Human Services

Class 2 Device Recall ARJO, Carendo MultiPurpose Hygiene Chair

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 Class 2 Recall
ARJO, Carendo MultiPurpose Hygiene Chair
see related information
Date Posted December 01, 2007
Recall Status1 Terminated on July 27, 2009
Recall Number Z-0261-2008
Recall Event ID 45402
Product Classification Lift, Patient, Non-Ac-Powered - 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, Illinois 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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