Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0261-2008 · Posted 2007-12-01

Recalling FirmArjo, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2007-10-15
Date Terminated2009-07-27
Product Quantity1,342 hygiene chairs

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑