{ "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": "105882", "product_res_number": "Z-0517-2012", "event_date_initiated": "2011-12-02", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-04-29", "res_event_number": "60583", "product_code": "BSR", "product_description": "Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia.\n\nUsed temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.", "code_info": "Catalog numbers: 502501, Lot numbers: 10JG05, 10JG28, 10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25, 11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21, 11FE24, 11GE29, 11GE30 and 11GG41.", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "2917 Weck Dr.", "city": "Research Triangle Park", "state": "NC", "postal_code": "27709", "additional_info_contact": "Robert Phillips\n610-378-0131", "reason_for_recall": "Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.", "root_cause_description": "Pending", "action": "The firm, Teleflex Medical, sent an \"Urgent Medical Device Recall Notification\" letter dated December 2, 2011 to its Consignees/Customers. The letter described the product, problem and actions to be take. The customers were instructed to immediately discontinue use and quarantine any products with the listed catalog and lot numbers; return the product; complete and return the enclosed Immediate Attention Requested Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service (a customer service representative will contact the customer with a returns good authorization number and provide instructions for the return of product to Teleflex medical), even if they have no affected product.\n\nIf you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.", "product_quantity": "73,281 units", "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.", "openfda": { "k_number": [ "K904999", "K912690", "K932081", "K920468", "K772046", "K844557", "K953677", "K162729", "K954771", "K843490", "K905052", "K952100", "K955238", "K935797", "K962361", "K802416", "K943104", "K910659", "K922842", "K952266", "K905133", "K914965", "K832773", "K950380", "K902180", "K940799", "K865108", "K921128", "K933598", "K770374", "K950713", "K944729" ], "registration_number": [ "", "3042022216", "3007829657", "3010594263", "1058584", "3006446479", "8020785", "3004056932", "3003528228", "3007728072", "1825146", "3005609751", "3013528571", "3010396739", "1423662", "1047843", "2025816", "2183828", "3042248499", "3015966505", "1045254", "3006787036", "3005327291", "3010202439", "3021010418", "9617604", "8022032", "3004527595", "3007421149", "9615393", "3010402691", "2022648", "9612501", "2032273", "3003213883", "3009746061", "3011600579", "3001313714", "3011497859", "1721686", "1720929", "3018094310", "3003898360", "3010149039", "3004111573", "2936999", "3022472", "1048735", "3000247987", "3002675176", "3011050534", "3014208300", "1314417", "3010041511", "9680143", "3004748541", "1061927", "2020550", "3016734145", "3003674698", "3030733800", "9613073", "8020889", "3006061749", "8040510", "3004992992", "3012494290", "3015216264", "2183650", "3018366470", "3005273623", "9680721", "8030673", "3018503755", "8040412", "3045058049", "3010400865", "3018762668", "3024026674", "9681384", "9680222", "3006973666", "1836161", "3009771213", "8044169", "3010131137", "9614084", "3011237770", "8021995", "3015152450", "3017166758", "3013557562", "3018074706", "3012970776", "1820334", "3013503739", "3011987967", "3000279801", "3009039068", "3013188547", "3014544429", "3016634868", "3013576541", "3003965134", "3011252788", "3008806809", "8040278", "3013412170", "3012287892", "3008808049", "3006389770", "3010220595", "3006210673", "3002807267", "9616567", "3007127332", "3022518300", "3020984207", "3006157842", "3003477135", "1928237", "3006897996", "2183744", "3006542380", "8010939", "3015142721", "3021244152", "3011137372", "3033010858", "3010834934", "3014579161", "3012991986", "3013055504", "3008676146" ], "fei_number": [ "", "3042022216", "3007829657", "1000219637", "3005747797", "3010594263", "3006446479", "3004056932", "3003528228", "3007728072", "1825146", "3005609751", "3013528571", "3010396739", "1047843", "2025816", "2183828", "3042248499", "3015966505", "1045254", "3006787036", "3005327291", "3021010418", "3004527595", "3001620388", "3007421149", "3004216008", "3010402691", "2022648", "3009291251", "3003213883", "3009746061", "3011600579", "3001717360", "3011497859", "3003154916", "3002750084", "1721686", "1720929", "3018094310", "3002807626", "3003898360", "3010149039", "3004111573", "2936999", "3022472", "3009271244", "1048735", "3001319476", "3000247987", "3002675176", "3011050534", "3014208300", "1314417", "3010041511", "3004748541", "3002808440", "2020550", "3016734145", "3003674698", "3030733800", "3005947796", "3003495548", "3006061749", "3004992992", "3012494290", "3015216264", "2183650", "3018366470", "3002807308", "3005273623", "3007475226", "3018503755", "3045058049", "3010400865", "3018762668", "3024026674", "3006973666", "3002963732", "3009771213", "3010131137", "3011237770", "3000215273", "3015152450", "3017166758", "1000283452", "3013557562", "3018074706", "3012970776", "1820334", "3013503739", "3011987967", "3000279801", "3009039068", "3000203000", "3013188547", "3014544429", "3016634868", "3013576541", "3003965134", "3011252788", "3002558692", "3006363476", "3008806809", "3003382061", "3013412170", "3012287892", "3008808049", "3006389770", "3010220595", "3006210673", "3002807267", "3007127332", "3022518300", "3020984207", "3006157842", "3003477135", "1928237", "3006897996", "2183744", "3006542380", "1000244733", "3003240904", "3015142721", "3004213967", "3021244152", "3003927064", "3033010858", "3010834934", "3014579161", "3012991986", "3002807293", "3013055504", "3008676146" ], "device_name": "Stylet, Tracheal Tube", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5790", "device_class": "1" } } ] }