{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203770", "product_res_number": "Z-0368-2024", "event_date_initiated": "2023-10-11", "event_date_posted": "2023-11-21", "recall_status": "Open, Classified", "res_event_number": "93237", "product_code": "BTM", "k_numbers": [ "K012842" ], "product_description": "Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: \n\n1.\tCuraplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; \n\n2.\tCuraplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; \n\n3.\tCuraplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; \n\n4.\tCuraplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; \n\n5.\tCuraplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.", "code_info": "UDI-DI: 00810071633126, Item # 2442-BVMCIN; \nUDI-DI: 00812277037050, Item # 2442-BVMPAD; \nUDI-DI: 00812277037074, Item # 2442-BVMPCH; \nUDI-DI: 00812277037081, Item # 2442-BVMPIN; \nUDI-DI: 00812277037067, Item # 2442-BVMPSA. \nAll lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.", "firm_fei_number": "1314417", "recalling_firm": "SunMed Holdings, LLC", "address_1": "2710 Northridge Dr Nw Ste A 2710 Northridge Dr Nw", "address_2": "Ste A", "city": "Grand Rapids", "state": "MI", "postal_code": "49544-9112", "additional_info_contact": "Jessica Hoke\n800-433-2797", "reason_for_recall": "A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.", "root_cause_description": "Device Design", "action": "Customer notification was emailed October 11, 2023 advising customers that monitoring of tidal carbon dioxide in critically ill patients is recommended because use of accessories (e.g. PEEP valve) on the exhalation port of manual resuscitators may increase backward leak in the integrated manometer due to increased expiratory resistance. This affects all lots with duckbill-style patient valve with integrated manometer manufactured since 09/21/2019. Customers are to disseminate this information to all users and complete and return the response for. The notice also notes manual resuscitator IFUs will be updated to include this information as a warning statement.", "distribution_pattern": "US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.", "openfda": { "k_number": [ "K974141", "K924215", "K912203", "K964719", "K181583", "K802231", "K834250", "K895169", "K880450", "K904346", "K771175", "K102649", "K922819", "K072021", "K982215", "K922712", "K014071", "K840935", "K832495", "K903443", "K972283", "K954866", "K895820", "K912620", "K073410", "K921982", "K913474", "K955507", "K964584", "K803066", "K900349", "K823408", "K863026", "K924217", "K922810", "K021716", "K930429", "K972139", "K874567", "K834400", "K884526", "K943617", "K843223", "K921553", "K881881", "K093081", "K002846", "K761065", "K831198", "K102824", "K842696", "K021442", "K912625", "K023494", "K881086", "K852096", "K073171", "K944347", "K953546", "K831885", "K895351", "K940581", "K042843", "K961369", "K991955", "K822356", "K894365", "K864125", "K881207", "K094003", "K901218", "K914196", "K875077", "K992057", "K874418", "K030864", "K961329", "K903438", "K924216", "K905002", "K042682", "K792118", "K842693", "K873043", "K874321", "K812022", "K051177", "K251631", "K952169", "K841496", "K922691", "K082092", "K152931", "K012271", "K913900", "K053142", "K954296", "K132172", "K791468", "K924671", "K924610", "K934699", "K014115", "K820059", "K923762", "K961331", "K973419", "K864308", "K031395", "K884068", "K892221", "K031434", "K771350", "K851171", "K882278", "K833244", "K913370", "K902733", "K981307", "K812273", "K831486", "K070247", "K170663", "K895589", "K961332", "K021446", "K920570", "K922707", "K933626", "K991861", "K973106", "K911298", "K885243", "K953617", "K971243", "K993194", "K934310", "K844729", "K970991", "K900260", "K062080", "K882285", "K873286", "K944301", "K981308", "K003927", "K842487", "K854037", "K952512", "K023793", "K012842", "K991953", "K032596", "K954150", "K881686", "K902261", "K021328", "K900577", "K953824", "K980066", "K802081", "K212905", "K822213", "K903570", "K913714", "K961868", "K910040", "K780216", "K860180", "K850436", "K883434", "K871147", "K844420", "K970756", "K961330", "K840349", "K243861", "K941037", "K970959", "K960468", "K921002", "K053466", "K210288", "K922004", "K993278", "K904899", "K961882", "K112852", "K915810", "K910856", "K896886", "K881087", "K905304", "K860693", "K823710", "K880394", "K914187", "K761025", "K221841", "K042556", "K903631", "K021390", "K802813", "K932797", "K963848", "K053140", "K911971", "K881483", "K911622" ], "registration_number": [ "3004993040", "3003898360", "3034669683", "3010402691", "9612374", "9610849", "3008818980", "3008806809", "3017708978", "3014656749", "3014579161", "3003862188", "3022631687", "9610483", "2030745", "2648727", "8044169", "1924066", "3011987967", "2024500", "8043316", "1314417", "3010272829", "3011137372", "3024753104", "3008729547", "3014507910", "3015191173", "2022648", "8021995", "1024404", "3005621729", "1526863", "9610861", "9617604", "3013484413", "3030308442", "9681848", "3036470679", "3008264081", "8030673", "9616445", "3008261717", "3007734888", "9616354", "3003924186", "3020460367", "9710391", "2020813", "3012104670", "2025816", "3011503227", "3013557562", "3006061749", "2518436", "2028807", "9610691", "3004365956", "2518157", "1417592", "3031369651", "3038772438", "3038430561", "1832562", "3003902679", "9710567", "3005609751", "3006783791", "3005587132", "3006157842", "3015997711", "3014220748", "3027977504", "3004111573", "3008311916" ], "fei_number": [ "3004993040", "3003898360", "3034669683", "3010402691", "3002807391", "3008818980", "3008806809", "3017708978", "3014656749", "3014579161", "3003862188", "3022631687", "2648727", "1924066", "3011987967", "2024500", "3002807836", "1314417", "3010272829", "3024753104", "3008729547", "3014507910", "3015191173", "2022648", "3005621729", "1024404", "1526863", "3005749238", "3003418980", "3013484413", "3030308442", "3003256355", "3036470679", "3008264081", "3002806359", "1000374126", "3008261717", "3007734888", "1000283452", "3003924186", "3002806674", "3020460367", "3004213967", "3012104670", "2020813", "3003319165", "2025816", "3011503227", "3013557562", "3006061749", "2518436", "3005747797", "3003202124", "3004365956", "2518157", "3000213164", "1417592", "3031369651", "3038772438", "3000204983", "3038430561", "1832562", "3003902679", "3006363476", "3006783791", "3005587132", "3005609751", "3015997711", "3006157842", "3002558692", "3014220748", "3002807435", "3027977504", "3004111573", "3008311916" ], "device_name": "Ventilator, Emergency, Manual (Resuscitator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5915", "device_class": "2" } } ] }