{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "149464", "product_res_number": "Z-0067-2017", "event_date_initiated": "2016-08-19", "event_date_posted": "2016-10-11", "recall_status": "Terminated", "event_date_terminated": "2019-07-19", "res_event_number": "75148", "product_code": "BSR", "product_description": "The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.", "code_info": "Model OL-E12102, lot# 101615.", "firm_fei_number": "3003213883", "recalling_firm": "Brathwaites Oliver Medical", "address_1": "96 Terracon Place", "city": "Winnipeg Canada", "state": "Manitoba", "reason_for_recall": "The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.", "root_cause_description": "Nonconforming Material/Component", "action": "On August 19, 2016 the firm sent a MEDICAL DEVICE RECALL NOTICE & CORRECTIVE ACTION letter to affected customers. The letter described the reason for the recall and necessary actions to be taken by the consignees. These included:\n\nBOMImed is requesting bougies with lot# 101615 to be returned for evaluation due a potential manufacturing concern.\n\nComplete the included Medical Device Recall Customer Letter and follow the instructions to obtain a Return Material Authorization number and\napplicable shipping instructions to return the affected products.\n\nBOMImed Regulatory department also requires the below Customer\nConfirmation section to be completed and return to\nregulatory@bomimed.com to confirm this notification was received.", "product_quantity": "760 units", "distribution_pattern": "U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada.", "openfda": { "k_number": [ "K920468", "K910659", "K952100", "K770374", "K935797", "K955238", "K950380", "K905133", "K844557", "K162729", "K953677", "K914965", "K922842", "K962361", "K802416", "K950713", "K905052", "K952266", "K921128", "K912690", "K932081", "K933598", "K843490", "K943104", "K954771", "K940799", "K832773", "K944729", "K902180", "K904999", "K772046", "K865108" ], "registration_number": [ "", "3042248499", "2936999", "1720929", "3014544429", "3010149039", "3018094310", "3002675176", "3010834934", "3010400865", "8040412", "3003477135", "3003898360", "3001313714", "3005609751", "3014208300", "3006787036", "3011252788", "3002807267", "8010939", "1825146", "3003674698", "8022032", "3013576541", "3045058049", "1045254", "9615393", "3008808049", "3009771213", "3011600579", "3042022216", "3015142721", "3013528571", "2025816", "3018074706", "9680222", "9616567", "3015216264", "3010220595", "3004111573", "3006061749", "3012991986", "1061927", "3020984207", "3012287892", "3006542380", "3006210673", "8040278", "3011237770", "3005273623", "2183650", "3013557562", "3010594263", "3024026674", "9680143", "1058584", "9680721", "3011987967", "3007421149", "3018762668", "3010041511", "3003213883", "9612501", "3016734145", "3021244152", "3010131137", "3011497859", "1820334", "3013188547", "3004748541", "2022648", "3022472", "8020889", "3013412170", "3018503755", "9613073", "3004527595", "3000279801", "9681384", "3012970776", "1836161", "3007728072", "2183744", "2032273", "3013055504", "1048735", "3004056932", "1928237", "3011137372", "3017166758", "9617604", "3033010858", "3018366470", "8030673", "3009039068", "3005327291", "1721686", "3010396739", "3006157842", "8021995", "3004992992", "3006446479", "3015152450", "1314417", "3010402691", "3012494290", "3006897996", "1047843", "3011050534", "3007127332", "3014579161", "3010202439", "8044169", "8020785", "3030733800", "3008676146", "3008806809", "3015966505", "1423662", "3016634868", "2020550", "3006389770", "3009746061", "3021284283", "3022518300", "3021010418", "9614084", "3003965134", "2183828", "3013503739", "3000247987", "3003528228", "8040510", "3006973666" ], "fei_number": [ "", "3042248499", "2936999", "3000203000", "1720929", "3014544429", "3010149039", "3018094310", "3002558692", "3002675176", "3010834934", "3010400865", "3003477135", "3003898360", "3005609751", "3014208300", "3006787036", "3000215273", "3011252788", "3002807267", "1825146", "3003674698", "3013576541", "3045058049", "1045254", "3008808049", "3009771213", "3011600579", "3002750084", "3002807293", "3042022216", "1000219637", "3015142721", "3013528571", "2025816", "3018074706", "3001620388", "3015216264", "3010220595", "3003240904", "3007475226", "3004111573", "3006061749", "3012991986", "3020984207", "3012287892", "3006542380", "3006210673", "3004216008", "3001319476", "3011237770", "3005273623", "2183650", "3013557562", "3010594263", "3024026674", "3011987967", "3007421149", "3018762668", "3010041511", "3003213883", "3016734145", "3021244152", "3010131137", "3011497859", "1820334", "3013188547", "3004748541", "2022648", "3022472", "3013412170", "3018503755", "3004527595", "3000279801", "3012970776", "3007728072", "2183744", "3003154916", "3013055504", "1048735", "3002807308", "3004056932", "3003495548", "1928237", "3017166758", "3033010858", "3018366470", "3006363476", "3009039068", "3005327291", "1721686", "3010396739", "1000244733", "3006157842", "3003382061", "3004992992", "3002807626", "3001717360", "3006446479", "3015152450", "1314417", "3005947796", "3010402691", "3012494290", "3006897996", "1047843", "3011050534", "3007127332", "3014579161", "3003927064", "3008676146", "3030733800", "3009271244", "3008806809", "1000283452", "3015966505", "3016634868", "3002963732", "3009291251", "2020550", "3006389770", "3009746061", "3021284283", "3022518300", "3021010418", "3004213967", "3003965134", "2183828", "3013503739", "3002808440", "3000247987", "3005747797", "3003528228", "3006973666" ], "device_name": "Stylet, Tracheal Tube", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5790", "device_class": "1" } } ] }