{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "65381", "product_res_number": "Z-0261-2008", "event_date_initiated": "2007-10-15", "event_date_posted": "2007-12-01", "recall_status": "Terminated", "event_date_terminated": "2009-07-27", "res_event_number": "45402", "product_code": "FSA", "product_description": "ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden", "code_info": "Model BIB2003-01, All Serial Numbers", "firm_fei_number": "1419652", "recalling_firm": "Arjo, Inc.", "address_1": "50 Gary Ave Ste A 50 Gary Ave", "address_2": "Ste A", "city": "Roselle", "state": "IL", "postal_code": "60172-1684", "additional_info_contact": "Ms. Traci Giovenco\n630-307-2756", "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_description": "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.", "product_quantity": "1,342 hygiene chairs", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K823206", "K851844", "K792601", "K840997", "K780684", "K811899", "K860837", "K930625", "K841395", "K844976", "K942807", "K841398", "K902141" ], "registration_number": [ "3015005479", "3004727093", "1058069", "3017264244", "1000153536", "3018117722", "3040280511", "1319061", "3007682310", "2320762", "1054241", "9615386", "3043654660", "8022890", "3043460907", "3016678044", "3027517735", "3004168774", "2183887", "9616091", "3005484027", "3030441550", "3005841027", "3014273557", "3007479130", "3007802293", "3042158935", "3007238754", "3034538639", "3001947547", "3026925581", "3009157571", "1221921", "2247992", "3005260401", "3033790380", "2182762", "3010359088", "3029906624", "3015173437", "3003775119", "3010010434", "3009425497", "3005748481", "3007309299", "3007231105", "3012643605", 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"3012292104", "3008370501", "3010472212", "3007048017", "3018229265", "3017375560" ], "device_name": "Lift, Patient, Non-Ac-Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.5510", "device_class": "1" } } ] }