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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 Device Recall ARJO Carendo MultiPurpose Hygiene Chairsee related information
Date Initiated by FirmJune 11, 2009
Date PostedSeptember 08, 2009
Recall Status1 Terminated 3 on August 19, 2010
Recall NumberZ-1946-2009
Recall Event ID 52232
Product Classification Lift, patient, non-ac-powered - Product Code FSA
ProductARJO 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.
FEI Number 3007515958
Recalling Firm/
Manufacturer		 ArjoHuntleigh
2349 W Lake St
Addison IL 60101-6183
For Additional Information ContactMs. 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		Device Design
ActionArjoHuntleigh 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 Commerce1,987 hygiene chairs
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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