{ "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": "31067", "product_res_number": "Z-0517-04", "event_date_initiated": "2003-12-23", "event_date_posted": "2004-02-10", "recall_status": "Terminated", "event_date_terminated": "2005-11-16", "res_event_number": "28029", "product_code": "BTM", "product_description": "LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.", "code_info": "All product shipped after 1/29/2003 is affected. The following lot numbers are the lot numbers for adult, pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE: customers were NOT provided with lot numbers. They were instructed to visually examine the Intake/Reservoir valve in order to determine if they have affected product.", "firm_fei_number": "2425852", "recalling_firm": "Laerdal Medical Corporation", "address_1": "167 Myers Corners Rd", "city": "Wappingers Falls", "state": "NY", "postal_code": "12590-3827", "additional_info_contact": "800-688-4391", "reason_for_recall": "Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.", "root_cause_description": "Other", "action": "Letters issued on 1/14/2004. The recall involves the replacement of the Inner Part of the Intake/Reservoir Valve, which is part of the Laerdal Silicone Resuscitator. Recall is to the user level.", "product_quantity": "2,153 units", "distribution_pattern": "Product was shipped to approximately 264 customers nationwide, and 3 foreign consignees (Mexico, Brazil and Northern Mariana Islands). Product was also sold to a few exporters who shipped units to unknown countries. Customers include distributors and end users. There were 2,403 parts shipped to Laerdal Medical Canada, Ltd., Toronto, Ontario, Canada. That firm is responsible for conducting an independent recall, reportedly with the knowledge of the Canadian government.", "openfda": { "k_number": [ "K864125", "K882278", "K900349", "K933626", "K930429", "K062080", "K771175", "K221841", "K924216", "K911298", "K922691", "K832495", "K073410", "K921002", "K892221", "K863026", "K981308", "K952512", "K912620", "K881686", "K831885", "K170663", "K854037", "K913900", "K003927", "K894365", "K014071", "K911622", "K842487", "K031434", "K900260", "K852096", "K973419", "K993194", "K841496", "K881483", "K014115", "K895351", "K874567", "K895820", "K874418", "K963848", "K913474", "K844420", "K021716", "K883434", "K102649", "K012842", "K961329", "K053142", "K181583", "K850436", "K012271", "K791468", "K093081", "K840349", "K961330", "K842693", "K881881", "K792118", "K953824", "K904899", "K934699", "K884068", "K780216", "K102824", "K915810", "K812273", "K914196", "K993278", "K924671", "K844729", "K840935", "K822213", "K881207", "K021390", "K961369", "K921553", "K981307", "K954296", "K042843", "K042682", "K761065", "K073171", "K771350", "K132172", "K941037", "K812022", "K971243", "K924610", "K970959", "K961868", "K964719", "K860693", "K895589", "K900577", "K902261", "K042556", "K875077", "K974141", "K822356", "K922819", "K023494", "K943617", "K871147", "K973106", "K912625", "K913370", "K873286", "K920570", "K903631", "K243861", "K934310", "K070247", "K972139", "K961882", "K895169", "K924215", "K834400", "K851171", "K901218", "K911971", "K903438", "K912203", "K802081", "K021328", "K982215", "K972283", "K961332", "K910040", "K903570", "K880394", "K023793", "K002846", "K803066", "K964584", "K970756", "K954150", "K860180", "K082092", "K953546", "K834250", "K053466", "K021446", "K831486", "K884526", "K932797", "K922712", "K952169", "K944347", "K913714", "K970991", "K210288", "K842696", "K802231", "K031395", "K094003", "K212905", "K880450", "K953617", "K922810", "K030864", "K992057", "K924217", "K874321", "K922707", "K831198", "K820059", "K053140", "K910856", "K251631", "K914187", "K991955", "K980066", "K960468", "K881086", "K864308", "K922004", "K843223", "K152931", "K923762", "K873043", "K940581", "K802813", "K761025", "K955507", "K881087", "K903443", "K905304", "K905002", "K072021", "K902733", "K032596", "K021442", "K961331", "K991861", "K921982", "K112852", "K944301", "K823408", "K882285", "K051177", "K833244", "K954866", "K823710", "K896886", "K991953", "K885243", "K904346" ], "registration_number": [ "3010402691", "3038430561", "3003898360", "3005587132", "9610483", "2025816", "3020460367", "3003924186", "3011503227", "9616445", "1924066", "3010272829", "9616354", "9710567", "3008729547", "3008261717", "3036470679", "2518157", "8043316", "9612374", "1024404", "9710391", "3006783791", "3013557562", "3013484413", "3014656749", "3011137372", "3011987967", "3024753104", "3005609751", "3006157842", "3008311916", "2024500", "3034669683", "3038772438", "2030745", "2020813", "3005621729", "3014220748", "3007734888", "1832562", "3015997711", "3012104670", "3031369651", "3008806809", "9617604", "3014579161", "3004111573", "1314417", "3006061749", "8044169", "3017708978", "2518436", "3008818980", "3003862188", "1417592", "3014507910", "3004365956", "3030308442", "8030673", "2022648", "3003902679", "2648727", "3015191173", "9681848", "9610849", "9610691", "9610861", "1526863", "3008264081", "3027977504", "2028807", "3022631687", "8021995", "3004993040" ], "fei_number": [ "3010402691", "3038430561", "3006363476", "3002807435", "3003898360", "3005587132", "3003418980", "2025816", "3003924186", "3020460367", "3011503227", "1924066", "3010272829", "3003256355", "3008729547", "3008261717", "3003319165", "3036470679", "1000283452", "2518157", "3004213967", "1024404", "3006783791", "3013557562", "3005749238", "3013484413", "1000374126", "3014656749", "3011987967", "3024753104", "3005609751", "3002807391", "3002807836", "3002558692", "3006157842", "3008311916", "2024500", "3034669683", "3038772438", "3003202124", "2020813", "3002806674", "3014220748", "3005621729", "3007734888", "3005747797", "3015997711", "1832562", "3012104670", "3031369651", "3008806809", "3014579161", "3004111573", "1314417", "3002806359", "3006061749", "3017708978", "2518436", "3008818980", "3003862188", "1417592", "3014507910", "3004365956", "3030308442", "3000204983", "2022648", "3003902679", "2648727", "3015191173", "3000213164", "1526863", "3008264081", "3027977504", "3022631687", "3004993040" ], "device_name": "Ventilator, Emergency, Manual (Resuscitator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5915", "device_class": "2" } } ] }