{ "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": 29 } }, "results": [ { "cfres_id": "168983", "product_res_number": "Z-0528-2019", "event_date_initiated": "2018-10-22", "event_date_posted": "2018-11-30", "recall_status": "Terminated", "event_date_terminated": "2020-04-03", "res_event_number": "81572", "product_code": "JSG", "product_description": "BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)", "code_info": "UDI - (01)10382902212611(17)181130  (10)8221508  Lot No.: 8221508  Expiration Date: 2018-11-30", "firm_fei_number": "1119779", "recalling_firm": "Becton Dickinson & Co.", "address_1": "7 Loveton Cir", "city": "Sparks", "state": "MD", "postal_code": "21152-9212", "reason_for_recall": "a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.", "root_cause_description": "Mixed-up of materials/components", "action": "Distributors were notified via email on October 22, 2018, requesting their customer distribution list. Customer letters were sent via UPS beginning on October 29, 2018. \n\n**Distributors are Advised to do the following:\n\n1.Discard any remaining inventory of the above referenced product. \n2.Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. \n3.Within three days, provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from your distribution branches so we may inform them of this issue. \nFax or email to: BD Regulatory Compliance\nFax: 410-316-4258\nEmail: BDRC2@bd.com\n4.A copy of the customer communication is attached for your records.\n\n**Customers area Advised to Take the Following Action(s):\n\n1. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. \n2. Discard any remaining inventory of lot 8221508. BD will process replacement of any discarded inventory upon receipt of the Customer Response Form.\n3. Share a copy of the Recall Letter with all users of the product within your facility to ensure awareness.\n\nCustomers with questions may call 800-638-8663, Monday through Friday 7 am - 7 pm, EST.", "product_quantity": "54,300 plates", "distribution_pattern": "US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV", "openfda": { "device_name": "Culture Media, Non-Selective And Non-Differential", "medical_specialty_description": "Microbiology", "regulation_number": "866.2300", "device_class": "1", "k_number": [ "K850847", "K881548", "K875273", "K881558", "K873220", "K844541", "K791698", "K850848", "K841130", "K881564", "K810553", "K870593", "K812732", "K833507", "K834319", "K811052", "K790621", "K831671", "K870133", "K821604", "K791631", "K872667", "K803025", "K800986", "K811051", "K834321", "K872668", "K851598", "K802415", "K812798", "K840069", "K834006", "K850549", "K844536", "K791544", "K833209", "K791562", "K880114", "K791628", "K811055", "K811606", "K864254", "K811050", "K841835", "K791620", "K811321", "K860411", "K800985", "K873222", "K881550", "K830077", "K812730", "K844538", "K832611", "K881546", "K841144", "K850842", "K791517", "K834206", "K830075", "K791516", "K850558", "K881554", "K792423", "K870592", "K881525", "K811729", "K791553", "K873236", "K834016", "K790459", "K881532", "K790375", "K830805", "K811735", "K811731", "K874538", "K812729", "K840072", "K834425", "K844529", "K790622", "K834427", "K860408", "K870595", "K873325", "K870800", "K830063", "K832534", "K792594", "K873257", "K811359", "K800981", "K811641", "K881543", "K811640", "K864255", "K791607", "K844528", "K833215", "K873053", "K811047", "K875136", "K811612", "K841143", "K811515", "K860403", "K870639", "K790497", "K872681", "K850733", "K875259", "K854455", "K881562", "K873221", "K842036", "K834323", "K862946", "K880947", "K881557", "K881522", "K880142", "K881542", "K833217", "K873235", "K873057", "K881533", "K872677", "K873219", "K811651", "K860409", "K834014", "K791622", "K833296", "K860397", "K870799", "K811734", "K760459", "K812795", "K833299", "K850998", "K873328", "K873217", "K834418", "K850658", "K791542", "K834324", "K881563", "K851250", "K873482", "K841203", "K834426", "K840518", "K860399", "K811353", "K873483", "K860401", "K844526", "K873062", "K873243", "K803023", "K760764", "K881545", "K812797", "K802892", "K830068", "K781604", "K873059", "K791630", "K881115", "K851601", "K830130", "K802397", "K841662", "K881541", "K873232", "K871098", "K811475", "K820559", "K881523", "K834322", "K871089", "K791943", "K792276", "K840077", "K882495", "K864240", "K801943", "K811340", "K820556", "K873480", "K811135", "K841303", "K870798", "K811654", "K844537", "K853690", "K843764", "K881531", "K801980", "K792543", "K820551", "K881528", "K872679", "K840075", "K861480", "K820791", "K820549", "K813232" ], "registration_number": [ "8044093", "3033815621", "2436875", "3022778613", "3024647994", "1125797", "3015825358", "3015715780", "1616487", "3005182159", "1220477", "3010420046", "3016587486", "3016619649", "1530248", "3016884191", "3002444944", "3017467459", "3017717188", "3009963993", "8010096", "9615755", "3016710934", "3017830316", "3009547954", "2016672", "3008236846", "3008007472", "3017871324", "3017231634", "3044466317", "1055236", "1924669", "1043214", "3020831613", "2030598", "3016764932", "1060680", "1054241", "1210083", "3005739529", "3005182157", "3000682787", "1111096", "2916932", "3009302820", "3015069920", "3016741564", "3045058049", "3018779125", "3011676045", "2022807", "3011649813", "3016837106", "1216735", "3016635427", "3017170972", "3038136284", "3015505238", "2951280", "1119779", "1450405", "3009171251", "8020040", "3018077536", "3012162776", "2919016", "1930987", "3007478714" ], "fei_number": [ "3022778613", "3033815621", "3024647994", "3015825358", "3015715780", "1616487", "3005182159", "1220477", "3010420046", "3016587486", "3016619649", "3016884191", "3002444944", "3017467459", "3017717188", "3009963993", "3016710934", "3017830316", "3003017595", "3009547954", "1924669", "3008236846", "3008007472", "3017871324", "3017231634", "3044466317", "1000208624", "1043214", "1000112968", "1000518731", "3016764932", "3020831613", "1210083", "3000206015", "3005739529", "3005182157", "3000682787", "1111096", "2916932", "3005729015", "3009302820", "3000974732", "3006759904", "3015069920", "3016741564", "3045058049", "3018779125", "3011676045", "2022807", "1000220444", "3011649813", "3016837106", "1216735", "3016635427", "3017170972", "3038136284", "3007808629", "3015505238", "1000112877", "1000221318", "1119779", "3006224287", "1450405", "3018077536", "3012162776", "2919016", "1930987", "3007478714", "1000521444" ] } } ] }