{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184796", "product_res_number": "Z-0741-2021", "event_date_initiated": "2020-11-11", "event_date_created": "2020-12-29", "recall_status": "Terminated", "event_date_terminated": "2023-02-07", "res_event_number": "86903", "product_code": "KGB", "k_numbers": [ "K913164" ], "product_description": "REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.", "code_info": "Lot # 091120N53", "firm_fei_number": "1000374126", "recalling_firm": "Westmed, Inc.", "address_1": "5580 S Nogales Hwy Ste 170 5580 S Nogales Hwy", "address_2": "Ste 170", "city": "Tucson", "state": "AZ", "postal_code": "85706-3333", "additional_info_contact": "Sarder Mostofa\n520-294-7987 Ext. 1244", "reason_for_recall": "There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.", "root_cause_description": "Process control", "action": "On November 11, 2020, West Med, Inc. issued a recall notification for oxygen delivery products via E-Mail to affected consignees. In addition to informing consignees about the recall products, the firm asked consignees to take the following actions:\n\n1. Please complete the attached response form and quarantine affected product. \n\n2. DO NOT DESTROY OR DISPOSE OF PRODUCT AT THIS TIME. \n\n3. Contact Kalyn Galvez-Latneau, Westmed Customer Service Manager, for additional information and to obtain a Return Material Authorization (RMA). Kalyn Galvez-Latneau, kgalvez@westmedinc.com, (520) 294-7987, Ext 1232.", "product_quantity": "3000 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom", "openfda": { "device_name": "Mask, Oxygen, Non-Rebreathing", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5570", "device_class": "1", "k_number": [ "K933583", "K790161", "K960401", "K930336", "K935917", "K941336", "K913164", "K933048", "K970688", "K883766", "K790162", "K781414", "K932347" ], "registration_number": [ "3008264111", "3015191173", "3022568093", "3010594263", "3005587132", "3020460367", "2020813", "3010656982", "3006446479", "3031369651", "3017937889", "3004056932", "3003528228", "3011529314", "1417592", "3029706818", "3005609751", "3014499739", "3038274448", "3015276580", "3007963782", "2025816", "3017171849", "3015495690", "3045526618", "3016450032", "3010957755", "3011983031", "3010380285", "9616354", "3008808560", "3034669683", "3013510193", "3010402691", "3013550220", "3031184338", "3016758972", "3007649127", "3017923969", "3003887292", "3013530901", "3011280379", "3009540516", "3016195240", "3012314549", "3012777736", "3013513837", "3005460813", "3009383647", "3012104670", "3008567544", "3013909820", "3026263452", "3004361444", "9710567", "3005621729", "3020777588", "3016937081", "3015745029", "3008808082", "3014437893", "3003622639", "3032579548", "3027645738", "3003244954", "3014208300", "9681848", "1314417", "3016452400", "3005621808", "1250045", "3016826509", "1024404", "3006547005", "3009171220", "3004748541", "3006534321", "3016734145", "3003674698", "3011716786", "2030745", "3015168843", "3029917416", "3006061749", "3034605486", "3008496560", "3015997711", "3001106688", "1420763", "9610861", "3005273623", "3008264242", "3000126629", "3017406698", "3018503755", "8030673", "3005669815", "3045058049", "3010400865", "3012711490", "3012250536", "9680222", "1836161", "3009771213", "3005767446", "3010131137", "1922553", "3004018264", "3027617478", "3013034812", "3017417635", "3003902312", "8021995", "3011185837", "3010583519", "3020751316", "3011987967", "3008384335", "3004488394", "8030607", "9710391", "3004993040", "3008806809", "3003698793", "3011310668", "3004134948", "3000153466", "3006210673", "3002807267", "3010452651", "3010272829", "3044150131", "3007127332", "3008818980", "3003862188", "3017202422", "9613418", "3006157842", "3006897996", "3038195661", "3010248787", "3012607778", "3004704697", "3030677", "3021244152", "3015058854", "2028807", "3017609572", "1924066", "3010834934", "3013055504", "3008676146" ], "fei_number": [ "3008264111", "3015191173", "3022568093", "3010594263", "3005587132", "3020460367", "2020813", "3010656982", "3006446479", "3031369651", "3017937889", "3004056932", "3003528228", "1000374126", "3011529314", "1417592", "3029706818", "3005609751", "3014499739", "3038274448", "3015276580", "3007963782", "2025816", "3017171849", "3015495690", "3045526618", "3016450032", "3010957755", "3011983031", "3010380285", "3034669683", "3013510193", "3010402691", "3013550220", "3031184338", "3016758972", "3007649127", "3017923969", "3003887292", "3013530901", "3011280379", "3009540516", "3016195240", "3003154916", "3002750084", "3012314549", "3012777736", "3013513837", "3005460813", "3009383647", "3012104670", "3008567544", "3013909820", "3006509795", "3026263452", "3004361444", "3003418980", "3005621729", "3020777588", "3016937081", "3015745029", "3008808082", "3014437893", "3003622639", "3032579548", "3027645738", "3003244954", "3014208300", "3001044237", "1314417", "3016452400", "3005621808", "1250045", "3016826509", "1024404", "3006547005", "3009171220", "3004748541", "3006534321", "3016734145", "3003674698", "3011716786", "3015168843", "3029917416", "3006061749", "3034605486", "3008496560", "3015997711", "3001106688", "3005273623", "3008264242", "3000126629", "3017406698", "3018503755", "3005669815", "3045058049", "3010400865", "3012711490", "3012250536", "3009771213", "3005767446", "3010131137", "1922553", "3004018264", "3027617478", "3013034812", "3017417635", "3003902312", "3011185837", "3010583519", "3020751316", "3003256355", "3011987967", "3008384335", "3004488394", "3002807836", "3004993040", "3006363476", "3008806809", "3003698793", "3011310668", "3004134948", "3000153466", "3006210673", "3002807267", "3010452651", "3004601847", "3010272829", "3044150131", "3007127332", "3008818980", "3003862188", "3017202422", "3006157842", "3006897996", "3038195661", "3010248787", "3012607778", "3004704697", "3004213967", "3021244152", "3015058854", "3000204983", "3017609572", "1924066", "3010834934", "3003202124", "3000213164", "1000524572", "1833338", "3013055504", "3008676146" ] } } ] }