Z-0261-2008

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

Name: Z-0261-2008 ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by...
Creator: Arjo, Inc.
Published: 2007-10-15
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2007-10-15 / Terminated / root cause: design

FDA source

Arjo, Inc. began a recall of ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden on 2007-10-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0261-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2007-12-01
Terminated: 2009-07-27
Recalling firm: Arjo, Inc.
Product: ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden
Product code: FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag: design
FDA root 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
Product codes and lots: Model BIB2003-01, All Serial Numbers

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)