{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198183", "product_res_number": "Z-1376-2023", "event_date_initiated": "2023-01-03", "event_date_posted": "2023-04-12", "recall_status": "Open, Classified", "res_event_number": "91561", "product_code": "CAN", "product_description": "Digital VIPR\n\nROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)\nROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder)\nMNDR-600, Western Oxytote DTE Digital VIPR (head only)\nMNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder)\nMNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)", "code_info": "ROC-9839, Roberts Oxygen Ready to Use Digital VIPR (head only)\no UDI-DI: B929ROC98390\n\nROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder)\no UDI-DI: B929ROC98400\n\nMNDR-600, Western Oxytote DTE Digital VIPR (head only)\no UDI-DI: B929MNDR6000\n\nMNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder)\no UDI-DI: B929MNDS6020\n\nMNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)\no UDI-DI: B929MNDS6030\n\nAll units distributed from 05/29/2020 to 12/7/2022.", "firm_fei_number": "1526809", "recalling_firm": "Western/Scott Fetzer Company", "address_1": "875 Bassett Rd", "city": "Westlake", "state": "OH", "postal_code": "44145-1142", "additional_info_contact": "Christine White\n440-871-2160", "reason_for_recall": "Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.", "root_cause_description": "Under Investigation by firm", "action": "On January 3, 2023, the firm issued a Safety Alert to customers. Customers were provided with updated operating instructions. Customers instructed to take the following immediate actions:\n\n1. Implement updated filling and venting instructions which include steps for the filler to verify proper gauge pressure after vent down and after fill/re-fill. \n\n2. Implement an additional verification of gauge pressure upon delivery at the healthcare facility.\n\n3. Take care to minimize any impact to the cylinder during use, transportation, or processing during fill/re-fill.\n\nThe firm continues to evaluate the gauge error issue and will implement additional corrective actions as appropriate.", "product_quantity": "24,287 units", "distribution_pattern": "US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.", "openfda": { "k_number": [ "K884927", "K872170", "K852663", "K862193", "K813466", "K912174", "K950777", "K861166", "K780364", "K852649", "K850106", "K810132", "K802644", "K891771", "K865077", "K863711", "K841367", "K936187", "K895956", "K893621", "K803207", "K061785", "K894302", "K896128", "K901623", "K932006", "K915154", "K896152", "K780359", "K771241", "K852333", "K830844", "K900115", "K901831", "K843585", "K844622", "K080243", "K915505", "K772216", "K811430", "K852374", "K813467", "K060265", "K853039", "K862796", "K780084", "K914271", "K883483", "K162811", "K894850", "K834061", "K810679", "K921125", "K942751", "K780750" ], "registration_number": [ "", "8010130", "3007360714", "3030128613", "1937613", "3013524663", "3029706818", "1000604079", "1000153536", "1526809", "3008774304", "2523148", "3005380088", "3020460367", "3008812560", "1530881", "1000359047", "3007222468", "2085336", "2085602", "9610861", "1836161", "3010834934", "3017406698", "3023809973", "1419185", "9611451", "3009512503", "3020188747", "3012971441", "1416980", "2020813", "3021244152", "3008808097", "3006446479", "9613416", "3008791328", "3012316249", "3012311599", "1062191", "3017181414", "1121335", "3020751316", "9614084", "3033959233", "3011237770", "2183615", "9681383", "3004859326", "1832475", "9710567", "1924066", "3007019343", "3008281139", "3004112621", "3006783791", "1044295", "1526863", "3002637618", "1610287", "9681409", "3004111085", "3008307149", "3034694958", "3013744387", "1000448358", "2030745", "1417592", "8020785", "3006563173", "3005206084", "2937398", "3014810929", "3006395447", "2183425", "3023339109", "3021841055", "9615102", "2025816", "3006157842", "3014273557", "3008264111", "3004034546", "2518435", "3003418325", "3006534178", "3043127556", "2020601", "3009327812", "3037012186", "3009291251", "9610105", "9616354", "9611500", "3020410611", "1017294", "3010373263", "3012777736", "3013156250", "3003207908", "3043047771", "3010394125", "3005448067", "3016426850", "3003674698", "3022528821", "3004145585", "3010387558", "3013557686", "3008115001", "2225311", "3005347827", "3013345545", "2432235" ], "fei_number": [ "", "3007360714", "3030128613", "1937613", "3013524663", "3029706818", "1000604079", "1000153536", "1526809", "3008774304", "2523148", "3005380088", "3020460367", "3008812560", "3002750084", "1000359047", "1000509422", "1000614294", "3007222468", "3000210616", "3001104093", "3010834934", "3017406698", "3023809973", "1419185", "3009512503", "3020188747", "3012971441", "1416980", "2020813", "3021244152", "3002297841", "3002807836", "3008808097", "3006446479", "3008791328", "3012316249", "3012311599", "3017181414", "1121335", "3002806783", "3020751316", "3033959233", "3011237770", "3005468265", "2183615", "3004859326", "1832475", "1924066", "3007019343", "3008281139", "3004112621", "3006783791", "3001655525", "1044295", "1526863", "3002637618", "1610287", "3004111085", "3008307149", "3034694958", "3013744387", "1000448358", "1000271197", "3001620388", "1417592", "3006563173", "3013345545", "2937398", "3014810929", "3006395447", "3005206084", "2183425", "3023339109", "3021841055", "2025816", "3006157842", "3014273557", "3008264111", "3004034546", "2518435", "3003418325", "3006534178", "3043127556", "2020601", "3009327812", "3037012186", "3009291251", "3020410611", "3003418980", "3000204983", "3002806988", "1017294", "3003256355", "3010373263", "3012777736", "3013156250", "3003207908", "3043047771", "1000306460", "3005448067", "3016426850", "3000719543", "3003674698", "3022528821", "3004145585", "3010387558", "3013557686", "3008115001", "2225311", "3005347827", "3010394125", "2432235" ], "device_name": "Regulator, Pressure, Gas Cylinder", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.2700", "device_class": "1" } } ] }