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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 September 08, 2009
Recall Status1 Terminated on August 19, 2010
Recall Number Z-1946-2009
Recall Event ID 52232
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. 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.
Code Information Model Number: BIB2003-01, all Serial Numbers below 0905000031.
Recalling Firm/
Manufacturer
ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
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 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.
Quantity in Commerce 1,987 hygiene chairs
Distribution Nationwide Distribution
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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