{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161605", "product_res_number": "Z-0817-2018", "event_date_initiated": "2017-09-22", "event_date_posted": "2018-03-01", "recall_status": "Terminated", "event_date_terminated": "2020-05-20", "res_event_number": "79196", "product_code": "DTN", "k_numbers": [ "K981284" ], "product_description": "Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)", "code_info": "**Recall expanded to add additional lot numbers highlighted with \"**\": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905", "firm_fei_number": "1000522036", "recalling_firm": "Circulatory Technology Inc", "address_1": "21 Singworth St", "city": "Oyster Bay", "state": "NY", "postal_code": "11771-3703", "additional_info_contact": "Yehuda Tamari\n516-624-2424", "reason_for_recall": "The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.", "root_cause_description": "Process control", "action": "The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to ytamari@cirtec.com as soon as possible.", "product_quantity": "840", "distribution_pattern": "**Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.", "openfda": { "k_number": [ "K883345", "K841175", "K132972", "K893705", "K903632", "K981284", "K941215", "K945065", "K033800", "K904040", "K930154", "K911790", "K051606", "K003551", "K964907", "K864895", "K852382", "K241053", "K913956", "K935717", "K920178", "K843888", "K984586", "K934763", "K933481", "K870829", "K022281", "K770546", "K873423", "K151110", "K122914", "K862357", "K024065", "K844367", "K872722", "K781577", "K011864", "K896414", "K102919", "K780517", "K832924", "K112771", "K982136", "K161733", "K033714", "K971669", "K831966", "K920312", "K871775", "K844229", "K001602", "K092315", "K851376", "K926250", "K971013", "K812008", "K994389", "K033641", "K984456", "K833479", "K905818", "K992599", "K981628", "K925046", "K802119", "K842391", "K061743", "K090534", "K141233", "K823272", "K812455", "K915737", "K842337", "K895076", "K843595", "K936286", "K842620", "K031150", "K770036", "K993001", "K990239", "K813268", "K002496", "K070605", "K132166", "K933713", "K083131", "K090690", "K974155", "K971105", "K050111", "K820727", "K934847", "K915573", "K911876", "K030726", "K882414", "K012942", "K241206", "K854841", "K802890", "K082082", "K844366", "K141432", "K872720", "K842711", "K251783", "K832671", "K930299", "K834373", "K872378", "K982223", "K920774", "K841031", "K902631", "K001822", "K936003", "K913915", "K862920", "K100507", "K964908", "K991973", "K030449", "K882380", "K884872", "K803059", "K821442", "K964973", "K153143", "K070839", "K050195", "K872721", "K812009", "K170583", "K072697", "K872719", "K760823", "K131103", "K031700", "K893711", "K913692", "K040023", "K972017", "K953821", "K841079", "K002238", "K980786", "K851401", "K841938", "K895356", "K013526", "K882720", "K823205", "K061527", "K021287", "K883923", "K081947", "K890077", "K961836", "K843232", "K832802", "K936183", "K955046", "K980935", "K894664", "K790635", "K140321", "K091062", "K223361" ], "registration_number": [ "9617601", "3019807891", "2184009", "3003752502", "2029275", "3009746061", "1928237", "3003661577", "3030125051", "3011554160", "1724474", "3008307705", "9681834", "1718850", "9680841", "3015136750", "3010084488", "3004080795", "1047843", "9612051", "8010026", "3002806603", "1124841", "1319639", "1625519", "3005941719", "3016746283", "3007829657", "2011171", "1643817", "3004548776", "3044156918" ], "fei_number": [ "3019807891", "3003094851", "3003752502", "2828", "1000116158", "3009746061", "1928237", "3002806457", "1000138054", "3003661577", "3030125051", "3011554160", "3008307705", "1000306431", "1718850", "3015136750", "3010084488", "3004080795", "3002808327", "1047843", "3005426550", "3002806603", "3002534070", "3002807111", "1625519", "3016746283", "3007829657", "2011171", "1643817", "3004548776", "3044156918", "3000204839" ], "device_name": "Reservoir, Blood, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4400", "device_class": "2" } } ] }