{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "95575", "product_res_number": "Z-0833-2011", "event_date_initiated": "2010-11-08", "event_date_posted": "2010-12-29", "recall_status": "Terminated", "event_date_terminated": "2012-03-16", "res_event_number": "57196", "product_code": "BTA", "k_numbers": [ "K062610" ], "product_description": "Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000\n\nThe device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.", "code_info": "Model 758000; Diode only: serial numbers CDF00000001 thru CDG00001052;  Screw only: serial numbers CDJ00000745 thru CDK00000667 Diode & replacement screw: serial numbers CDG00001053 thru CDJ00000744", "firm_fei_number": "1419185", "recalling_firm": "Ohio Medical Corporation", "address_1": "1111 Lakeside Dr", "city": "Gurnee", "state": "IL", "postal_code": "60031", "additional_info_contact": "Ms. Anita Christ\n847-855-6222", "reason_for_recall": "The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened.", "root_cause_description": "Device Design", "action": "Ohio Medical sent Urgent Medical Device Correction Notification letters dated November 4, 2010, to all affected customers on November 8, 2010. The letters identified the product, the problems, and the action to be taken by the customer.\nCustomers were instructed to take the affected product out of service, remove diode 14, and replace the foot screw contained therein. Customers were instructed to visit the micro-sites established for these repair procedures for step-by-step instructions on performing the repairs. Accounts with questions after viewing the video demonstration were directed to the Ohio Medical technical assistance line at 224-430-1522. \nCustomers were asked to complete the attached Customer Acknowledgment Form and return the form to the Quality Assurance Department at (fax) 1.847.855.6304, or e-mail to:\nComplaints@OhioMedical.com, or mail to:\nOhio Medical Corproation\nQuality Assurance\n1111 Lakeside Drive\nGurnee, Illinois 60031.\n\nFor questions regarding this recall call 847-855-6270.", "product_quantity": "4,183 units", "distribution_pattern": "Worldwide Distribution - USA nationwide, Puerto Rico, and the coutries of Canada, Israel, Jordan, Kenya, Kuwait, Saudi Arabia, Taiwan, Thailand and Vietnam.", "openfda": { "k_number": [ "K253629", "K231063", "K130131", "K831085", "K250697", "K944399", "K873940", "K832274", "K862569", "K970186", "K232831", "K122619", "K130123", "K040239", "K153663", "K942033", "K954286", "K241852", "K952806", "K093241", "K810490", "K831007", 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"K244033", "K926566", "K940934", "K954264", "K140179", "K874157", "K871570", "K841903", "K241202", "K080745", "K843644", "K221042", "K821321", "K945929", "K130210", "K233901", "K180606", "K854844", "K041154", "K260473", "K951326", "K842204", "K051758", "K933902", "K813095", "K932494", "K950495", "K820338", "K222547", "K860030", "K011601", "K242028", "K980392", "K813312", "K944818", "K021368", "K161002", "K971107", "K862751", "K941096", "K944116", "K081185", "K153459", "K862875", "K253107", "K080212" ], "registration_number": [ "3004378299", "3031563234", "3009538961", "2022724", "3009039068", "1219343", "3004464325", "3019924", "3007360714", "3004727197", "3003781173", "3003509351", "3029871637", "3006617533", "1450908", "3010659128", "2134752", "3007305485", "3011716786", "3007143859", "3004443928", "9611174", "9610612", "3006789357", "3017435705", "3010202439", "9680961", "3008837339", "3015924074", "3013298431", "3017493034", "3013556777", "3004050971", "3013095415", "3021376102", "3016661562", "3005146144", "8010573", "2523148", "3021595514", "3011050570", "3005168196", "9610617", "3012322232", "3011816507", "9614434", "1924066", "3038634684", "3016904853", "2024022", "1000122786", "1649660", "3014718111", "1043214", "1220908", "3005803793", "9680741", "3014827316", "3012684779", "1060680", "1000604079", "2132111", "1417592", "3005527904", "3006174295", "3015177409", "3017520736", "3005813597", "3025428426", "3038259592", "9614936", "3026986849", "9617543", "3010707607", "3027605322", "3015615738", "9613895", "3013758550", "2020550", "3014342096", "1721676", "3013857114", "3010034780", "3014273557", "1419185", "1419937", "3020476987", "3002807523", "9617787", "2032112", "3004145393", "3016591327", "3006142527", "3010079067", "3023876581", "3042156936", "3012797688", "9610861", "3004993040" ], "fei_number": [ "3004378299", "3031563234", "1000208624", "3009538961", "2022724", "3009039068", "1219343", "3004464325", "3002808268", "3019924", "3007360714", 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"3013857114", "3010034780", "3014273557", "1419185", "1419937", "3020476987", "3002807523", "3004145393", "3016591327", "3006142527", "3010079067", "3023876581", "3042156936", "3012797688", "3004993040" ], "device_name": "Pump, Portable, Aspiration (Manual Or Powered)", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4780", "device_class": "2" } } ] }