{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "75692", "product_res_number": "Z-0863-2009", "event_date_initiated": "2008-10-27", "event_date_posted": "2009-02-10", "recall_status": "Terminated", "event_date_terminated": "2012-09-25", "res_event_number": "50522", "product_code": "JCX", "k_numbers": [ "K982304" ], "product_description": "DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.", "code_info": "Model number 7310PR-D. Serial numbers PRD000006, PRD000012, PRD000013, PRD000014, PRD000046, PRD000082, PRD000083, PRD000084, PRD000088, PRD000090, PRD000091, PRD000099, PRD000100, PRD000101, PRD000102, PRD000152, PRD000174, PRD000175, PRD000177, PRD000184, PRD000186, PRD000189, PRD000191, PRD000193, PRD000201, PRD000202, PRD000203, PRD000206, PRD000207, PRD000209, PRD000225, PRD000226, PRD000229, PRD000230, PRD000262, PRD000269, PRD000323, PRD000341, PRD000355, PRD000363, PRD000364, PRD000368, PRD000370, PRD000371, PRD000373, PRD000374, PRD000375, PRD000383, PRD000385, PRD000386, PRD000388, PRD000389, PRD000390, PRD000392, PRD000393, PRD000399, PRD000400, PRD000401, PRD000403, PRD000405, PRD000406, PRD000407, PRD000409, PRD000411, PRD000415, PRD000417, PRD000419, PRD000420, PRD000422, PRD000425, PRD000426, PRD000428, PRD000432, PRD000443, PRD000447, PRD000448, PRD000449, PRD000450, 0425198002000, and 04275195001000", "firm_fei_number": "2515872", "recalling_firm": "Sunrise Medical", "address_1": "100 Devilbiss Dr", "city": "Somerset", "state": "PA", "postal_code": "15501-2125", "additional_info_contact": "Devilbiss Customer Service\n800-338-1988", "reason_for_recall": "Improper suction: Regulator knob does not turn properly which can affect the suction level.", "root_cause_description": "Device Design", "action": "DeVilbiss notified dealers and users (through the dealers) to recall the units, by a telephone call October 27, 2008 followed by an Urgent Medical Device Recall mailing November 3, 2008. The letter advised customers what models are affected and how to contact the firm of dealer to have the affected unit replaced. Corrective and preventative action on current manufacturing has been implemented.", "product_quantity": "78 units", "distribution_pattern": "Worldwide Distribution: USA, Mexico, Guatemala, Colombia, and Costa Rica.", "openfda": { "k_number": [ "K132671", "K001716", "K792592", "K820331", "K090759", "K082762", "K243638", "K935218", "K102626", "K182950", "K920288", "K930852", "K841538", "K153407", "K131099", "K233428", "K123188", "K133196", "K140031", "K180115", "K103535", "K791239", "K791210", "K982304", "K080005", "K801043", "K140809", "K963558", "K945062", "K172481", "K801349", "K791238", "K841160", "K042349", "K222552", "K832301", "K941524", "K895761", "K162421", "K112421", "K872094", "K791240", "K251111", "K940886", "K080845", "K914177", "K843081", "K941525", "K944119", "K190789", "K974038", "K132308", "K820330", "K081047", "K842050", "K181398", "K791241", "K930030", "K122756", "K950698", "K063448", "K190105", "K771071", "K914694", "K941527", "K250964", "K133786", "K930900", "K060277", "K161358", "K130001", "K941526", "K243418", "K120065", "K900430", "K920287", "K011725" ], "registration_number": [ "3030733800", "", "3021009035", "3004993040", "3013758550", "3004598644", "2031894", "3010079067", "2225311", "1055236", "3011418975", "3012494290", "3006535925", "9616843", "3006446479", "1526350", "3014810929", "3013556777", "3007997036", "3032391", "3003144120", "3011683674", "9611102", "3012497308", "2246552", "1317202", "1043214", "3003803075", "3003627840", "3010399798", "3015615738", "3036756245", "3003542872", "3015550451", "3025603301", "3006142527", "3015542154", "2029214", "3007127244", "2022724", "3004112621", "3016678045", "3003595343", "3015967359", "3021244152", "8022210", "3008220943", "3016591327", "1054241", "3006789357", "3005168196", "3007682555", "9611665", "3047841690", "2320762", "3013666218", "1924066", "2249651", "3010834934", "3008363932", "3006395447", "3014590707", "3015207155", "3012316249", "2431273", "3033509898", "2515872" ], "fei_number": [ "3030733800", "", "3021009035", "3004993040", "3013758550", "3004598644", "2225311", "3010079067", "3004099094", "3002771993", "1000112877", "3011418975", "3012494290", "3006535925", "3006446479", "1526350", "3014810929", "1000220862", "3013556777", "3007997036", "3011683674", "3003188183", "3012497308", "3003040625", "2246552", "1317202", "3002299608", "1043214", "3001099558", "1000112968", "3003803075", "3003627840", "3010399798", "3015615738", "3036756245", "3932", "3003542872", "3015550451", "3025603301", "3006142527", "3015542154", "3007127244", "2022724", "3004112621", "3016678045", "3003595343", "3015967359", "3021244152", "3005168196", "3008220943", "3016591327", "3006789357", "3002807095", "3007682555", "3047841690", "3013666218", "1924066", "3010834934", "3008363932", "3006395447", "3014590707", "3015207155", "3012316249", "2431273", "3002808001", "3033509898", "2515872" ], "device_name": "Apparatus, Suction, Ward Use, Portable, Ac-Powered", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4780", "device_class": "2" } } ] }