{ "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": "189899", "product_res_number": "Z-0269-2022", "event_date_initiated": "2021-10-16", "event_date_created": "2021-11-19", "recall_status": "Open, Classified", "res_event_number": "88877", "product_code": "CAN", "product_description": "Western Oxytote DTE Digital VIPR System (with D-size cylinder)\n\nModel: MNDS-602", "code_info": "Units distributed from 05/29/20 to 08/31/21.\n\nDigital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)", "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": "Kellie Wargo\n800-783-7890", "reason_for_recall": "VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke", "root_cause_description": "Device Design", "action": "Western / Scott Fetzer Co. issued Urgent Medical device Recall letter, dated 10/15/21 distributed via USPS to consignees on 10/16/21, and emailed to the same consignees on 10/18/21. Letter states reason for recall , health risk and action to take:\nFill facility employees are asked to verify the functionality of each unit through the observation of information on the digital display. Note that this direction and expectation is already clearly indicated in the product Operating Instructions and Inspection Guidelines.\nIf the digital display shows the expected information as depicted in the Operating Instructions and Inspection Guidelines, the unit is functioning properly and may remain in use.\nIf the digital display is blank, the unit is to be isolated and returned to Western for inspection.\nAs a longer term solution, beginning in October 2021, product within the scope of the recall is to be corrected as follows:\n1. For Digital VIPR products that do not include a cylinder (MNDR-600), units will be returned to Western via RGA to perform the following services:\n\" Remove shroud from unit to determine battery type used\n\" If 3500mAh battery found, replace it with 4000mAh battery\n\" If 4000mAh battery found, inspect for battery lead wire damage, replace if damage found\n\" Remove potential burr / sharp edge from screw boss on regulator body\n\" Replace back shroud with modified back shroud (pinch points removed)\n\" Reassemble unit per revised assembly procedure\n\" Apply new control knob sticker (green logo, silver background)\nPage 3 of 6\n2. For Digital products that include a cylinder (ROC-9840 and MNDS-602), Western employees will visit customer fill facility locations to perform the following services:\n\" Remove shroud from unit to determine battery type used\n\" If 3500mAh battery found, replace it with 4000mAh battery\n\" If 4000mAh battery found, inspect for battery lead wire damage, replace if damage found\n\" Remove potential burr / sharp edge from screw boss on regulator body\n\" Re", "product_quantity": "40 units", "distribution_pattern": "CT, MD, MT, OH", "openfda": { "k_number": [ "K852649", "K771241", "K894302", "K900115", "K844622", "K883483", "K893621", "K872170", "K932006", "K896152", "K802644", "K852663", "K830844", "K912174", "K914271", "K891771", "K915154", "K810679", "K894850", "K813466", "K884927", "K850106", "K772216", "K162811", "K896128", "K834061", "K915505", "K780359", "K863711", "K841367", "K811430", "K853039", "K895956", "K810132", "K901831", "K813467", "K843585", "K865077", "K803207", "K852333", "K061785", "K921125", "K852374", "K862796", "K780750", "K780364", "K950777", "K780084", "K080243", "K901623", "K060265", "K936187", "K861166", "K862193", "K942751" ], "registration_number": [ "", "1000604079", "3037012186", "3021841055", "3012311599", "3006395447", "3008281139", "1526863", "3013345545", "1832475", "9681383", "3008774304", "2085336", "8020785", "2523148", "3004111085", "2518435", "3034694958", "1121335", "1000448358", "3008115001", "3017406698", "3013524663", "3020188747", "3012971441", "2085602", "3008264111", "3004859326", "9614084", "9681409", "3010834934", "3004112621", "3011237770", "3003674698", "3013557686", "3005347827", "3020460367", "3010387558", "1000153536", "3009327812", "3043127556", "2025816", "3004034546", "1000359047", "1417592", "1044295", "1836161", "9611451", "3006783791", "3012316249", "3003418325", "1610287", "3023809973", "3007222468", "1526809", "3005448067", "1924066", "3014810929", "1937613", "3033959233", "3006534178", "1416980", "3010373263", "3012777736", "9613416", "3005380088", "3006563173", "9616354", "3020751316", "2020813", "3006446479", "2020601", "1062191", "3009512503", "1017294", "3007360714", "3002637618", "2432235", "3006157842", "2183425", "3013744387", "2225311", "9611500", "1419185", "3008307149", "3008808097", "3022528821", "3007019343", "2937398", "3021244152", "3003207908", "2030745", "8010130", "3005206084", "3013156250", "9610861", "3014273557", "3020410611", "3017181414", "1530881", "3008812560", "9615102", "3029706818", "3008791328", "2183615", "3023339109", "3030128613", "3009291251", "9710567", "3043047771", "9610105", "3016426850", "3010394125", "3004145585" ], "fei_number": [ "", "1000604079", "3037012186", "3021841055", "3012311599", "3001655525", "3006395447", "3008281139", "1526863", "3013345545", "1832475", "3008774304", "2523148", "3004111085", "2518435", "3034694958", "1121335", "1000448358", "3008115001", "3017406698", "3013524663", "3020188747", "3012971441", "3008264111", "3004859326", "3002807836", "3003418980", "3010834934", "3004112621", "3011237770", "3003674698", "3005468265", "3013557686", "3001620388", "3005347827", "3002806783", "3010387558", "3020460367", "1000271197", "1000153536", "3009327812", "3043127556", "2025816", "3004034546", "1000359047", "1417592", "1044295", "3000210616", "3012316249", "3006783791", "3003418325", "1610287", "3023809973", "3002750084", "3007222468", "1526809", "3005448067", "1924066", "3014810929", "3002297841", "1937613", "3001104093", "3033959233", "1000509422", "3006534178", "1416980", "3010373263", "3003256355", "3012777736", "3005380088", "1000614294", "3006563173", "3020751316", "3000719543", "2020813", "3006446479", "2020601", "3009512503", "1017294", "3007360714", "3002637618", "2432235", "3006157842", "3002806988", "2183425", "3013744387", "2225311", "1419185", "3008307149", "3008808097", "3022528821", "3007019343", "2937398", "3021244152", "3003207908", "3005206084", "3013156250", "3014273557", "3020410611", "1000306460", "3017181414", "3008812560", "3029706818", "3008791328", "2183615", "3023339109", "3030128613", "3009291251", "3000204983", "3043047771", "3016426850", "3010394125", "3004145585" ], "device_name": "Regulator, Pressure, Gas Cylinder", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.2700", "device_class": "1" } } ] }