{ "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": "139626", "product_res_number": "Z-0245-2016", "event_date_initiated": "2015-08-24", "event_date_posted": "2015-11-06", "recall_status": "Terminated", "event_date_terminated": "2017-09-25", "res_event_number": "72037", "product_code": "BSR", "product_description": "Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.", "code_info": "Material #502501, Batch numbers: 12EE20, 12FE26, 12GE27, 12IE37, 12GE30, 13AG21, 12LG29, 12IE36, 12IE39, 13DG06, 12JE41, 12KE48, 13BG26, 13BG36, 13DG24, 14FG03, 14GG01, 14GG03, 14HE32, 14HE34, 14IE36, 14KG11, 14JG05, 14JE43, 14KG27, 14LG06, 15BG05, 15AG34, 15AG28, 15CG24, 15DE18, 15DG38, and 15EG08.", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "2917 Weck Dr", "city": "Research Triangle Park", "state": "NC", "postal_code": "27709-0186", "additional_info_contact": "Jennifer E. Suh\n610-378-0131 Ext. 60347", "reason_for_recall": "Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to recalls@teleflex.com, even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.", "product_quantity": "233,641 units", "distribution_pattern": "Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.", "openfda": { "k_number": [ "K902180", "K904999", "K962361", "K920468", "K921128", "K943104", "K955238", "K922842", "K933598", "K954771", "K935797", "K905133", "K950380", "K944729", "K950713", "K914965", "K940799", "K952100", "K952266", "K162729", "K912690", "K932081", "K832773", "K802416", "K844557", "K865108", "K770374", "K843490", "K772046", "K905052", "K953677", "K910659" ], "device_name": "Stylet, Tracheal Tube", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5790", "device_class": "1", "registration_number": [ "3003898360", "", "3030733800", "3012494290", "8010939", "3010149039", "3018094310", "8020889", "3004056932", "8021995", "3013055504", "3013188547", "1048735", "3006389770", "3009039068", "3017166758", "3022518300", "8020785", "3015142721", "3020984207", "3003965134", "3013557562", "3006061749", "3006542380", "3011497859", "9681384", "3013503739", "3018503755", "1928237", "1720929", "3012287892", "3007728072", "3004111573", "8040278", "3008676146", "3018366470", "3042248499", "3006897996", "3002675176", "3016634868", "1314417", "9614084", "2022648", "8022032", "3010396739", "3004748541", "1423662", "3010834934", "3011237770", "3008808049", "1721686", "3000279801", "8030673", "3004527595", "3003528228", "3011600579", "2936999", "3003674698", "3007127332", "3001313714", "3015152450", "3006787036", "3010131137", "9680143", "2025816", "3006973666", "2183828", "1836161", "1058584", "1825146", "3004992992", "3010402691", "3016734145", "3008806809", "3022472", "8044169", "3005327291", "9680222", "9616567", "2183650", "3011252788", "3042022216", "2032273", "2020550", "3010041511", "3010202439", "3003213883", "3015966505", "3014208300", "3010220595", "3012991986", "3033010858", "2183744", "3045058049", "3006446479", "8040412", "3010594263", "1047843", "3021284283", "3006157842", "3021010418", "3014544429", "3011050534", "3006210673", "3014579161", "3000247987", "3021244152", "3018762668", "9612501", "3011987967", "3009771213", "3013528571", "3011137372", "3024026674", "9617604", "8040510", "3015216264", "9613073", "9615393", "1061927", "3007421149", "3003477135", "3005273623", "3012970776", "9680721", "3018074706", "3010400865", "3009746061", "1045254", "3005609751", "1820334", "3013576541", "3013412170", "3002807267" ], "fei_number": [ "3003898360", "", "1000219637", "3030733800", "3012494290", "3010149039", "3018094310", "3002807293", "3004056932", "3013055504", "3013188547", "1048735", "3006389770", "3003382061", "3009039068", "3017166758", "3022518300", "3002807626", "3003154916", "3003240904", "3015142721", "3020984207", "3004213967", "3003965134", "3013557562", "3006061749", "3005747797", "3006542380", "3011497859", "3013503739", "3018503755", "1928237", "1720929", "3012287892", "3007728072", "3004111573", "3008676146", "3018366470", "3042248499", "3006897996", "3002675176", "3016634868", "1314417", "2022648", "3010396739", "3004748541", "3010834934", "3011237770", "3008808049", "1721686", "3000279801", "3011600579", "3004527595", "3003528228", "3003674698", "2936999", "3001620388", "3007127332", "3000203000", "3015152450", "3006787036", "3010131137", "3000215273", "2025816", "3006973666", "2183828", "3006363476", "1000283452", "1825146", "3004992992", "3010402691", "3002750084", "3016734145", "3008806809", "3022472", "3003495548", "3003927064", "3005327291", "3007475226", "3002807308", "2183650", "3011252788", "3042022216", "2020550", "3010041511", "3001319476", "3003213883", "3015966505", "3014208300", "3010220595", "3012991986", "3033010858", "2183744", "3045058049", "3006446479", "3002808440", "3010594263", "1047843", "3001717360", "3021284283", "3006157842", "3021010418", "3014544429", "3011050534", "3006210673", "3014579161", "3000247987", "3021244152", "3018762668", "3011987967", "3009771213", "3013528571", "3009271244", "3004216008", "3024026674", "3005947796", "3015216264", "1000244733", "3007421149", "3003477135", "3005273623", "3012970776", "3002963732", "3018074706", "3010400865", "3009746061", "3009291251", "1045254", "3005609751", "3002558692", "1820334", "3013576541", "3013412170", "3002807267" ] } } ] }