{ "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": 97 } }, "results": [ { "cfres_id": "85630", "product_res_number": "Z-0039-2010", "event_date_initiated": "2009-10-06", "event_date_posted": "2009-11-04", "recall_status": "Terminated", "event_date_terminated": "2010-08-10", "res_event_number": "53489", "product_code": "BTM", "k_numbers": [ "K873286" ], "product_description": "Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206.\n\nPackaged under the name of Dynarex, Evergreen, Mada and Hospitak.\nRecalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.", "code_info": "Product ID # 5801; Lot numbers 07-39, 07-49; Product ID # 12-8713; lot numbers: 04-08 04-18 04-28 06-11 06-26 07-07 07-12 07-14; Product ID # 732-E; lot numbers: 03-11 03-22 03-25 03-29 03-34 03-42 04-05 04-42 05-12 05-32 05-34 05-42 05-43 06-04 06-19 06-30 07-12 07-20 07-25 07-30 07-35 07-38 07-43 07-47; Product ID # 2206; lot number: 04-05.", "firm_fei_number": "1000160240", "recalling_firm": "Unomedical", "address_1": "5701 S Ware Rd", "city": "Mcallen", "state": "TX", "postal_code": "78503-7795", "additional_info_contact": "Raymond Mendoza\n800-634-6003", "reason_for_recall": "In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.", "root_cause_description": "Device Design", "action": "Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product.\nContact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.", "product_quantity": "over 200 total lots", "distribution_pattern": "Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.", "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" } } ] }