{ "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": "184340", "product_res_number": "Z-0868-2021", "event_date_initiated": "2020-12-18", "event_date_created": "2021-01-15", "recall_status": "Terminated", "event_date_terminated": "2023-12-11", "res_event_number": "86702", "product_code": "JCX", "k_numbers": [ "K120065" ], "product_description": "Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers \n880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.", "code_info": "Serial number range 1808090001 to 2006060045", "firm_fei_number": "3004993040", "recalling_firm": "Laerdal Medical (Suzhou) Co., Ltd.", "address_1": "Science & Technology Ind. Park No. 19 Bldg. Huoju Road", "city": "Suzhou", "country": "China", "additional_info_contact": "Laerdal Sales Office\n877-5237325 Ext. 3234", "reason_for_recall": "Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.", "root_cause_description": "Device Design", "action": "On December 18, 2020, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were informed that the service life of the LCSU 4 may be reduced. Customers were asked to identify and secure affected units. Customers were told that they could continue to use their LCSU 4 unit until they receive a replacement unit, but were provided with safety measures:\n\n- Follow local protocols for back-up suction devices. Do not repeatedly block the patient tube for\nmore than 10 seconds at a time at vacuum levels greater than 300 mmHg.\n- Only use canisters, tubes and accessories that are approved for the device by Laerdal Medical.\n- When adjusting the vacuum level: When the desired vacuum level is reached; unblock the patient\ntube immediately.\n- During patient treatment do not occlude or block the patient tube by intentional bending or\nsqueezing. The patient tube should only be temporarily occluded by suctioning matter.\n- When performing the Device Test: When the vacuum reaches minimum 500 mmHg immediately\nrelease the blocking.\n- If your affected LCSU 4 experiences a loss of peak suction, please report this to your local Laerdal\nSales office, for US: 877-LAERDAL (523-7325), customerservice@laerdal.com or,\nfor Canada: (416) 298-9600, savelives@laerdal.com\n\nCustomers must complete the included reply form to acknowledge receipt of the recall notice and to identify any units needing replacement, and return the information to Stericycle.", "product_quantity": "5035", "distribution_pattern": "Worldwide distribution - US Nationwide distribution.", "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" } } ] }