ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital

FDA device recall Z-0261-2008 · posted 2007-12-01 · Terminated

Recall details

Recalling firm

Arjo, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

1,342 hygiene chairs

Distribution

Nationwide

Date initiated

2007-10-15

Date posted

2007-12-01

Date terminated

2009-07-27

Location

Roselle, IL