FDA Recall Terminated

ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. The equipment is intended for hygiene care, showering, and toileting of hospital or nursing home residents under the supervision of trained nursing staff and in accordance with the instructions outlined in the Operating and Product Care Instructions.

Recall: Z-1946-2009 · Initiated June 11, 2009

Recall

Recall Number
Z-1946-2009
Event Number
52232
Firm
ArjoHuntleigh
FEI Number
3007515958
Product Code
FSA
Status
Terminated
Root Cause
Device Design
Initiated
June 11, 2009
Posted
September 8, 2009
Terminated
August 19, 2010
Address
2349 W Lake St, Addison, IL, 60101-6183

Description

ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. The equipment is intended for hygiene care, showering, and toileting of hospital or nursing home residents under the supervision of trained nursing staff and in accordance with the instructions outlined in the Operating and Product Care Instructions.

Reason

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

ArjoHuntleigh sent Urgent Device Field Correction letters dated June 11, 2009, along with the Urgent Field Safety Notice ID 090526AHE dated May 26, 2009, via UPS Ground delivery. Customers were informed of the affected device and were requested to complete the response form with new contact information and fax it back to ArjoHuntleigh at 630-567-5012 or 630-925-7969. For further questions, contact ArjoHuntleigh at 1-800-323-1245.

Distribution

Nationwide Distribution

Quantity

1,987 hygiene chairs