{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "187628", "product_res_number": "Z-1862-2021", "event_date_initiated": "2021-04-27", "event_date_created": "2021-06-15", "recall_status": "Open, Classified", "res_event_number": "88000", "product_code": "DTN", "k_numbers": [ "K981284" ], "product_description": "The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14", "code_info": "Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021", "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": "On April 27, 2021, CTI issued an Urgent Medical Device Removal notice to customers via email and phone, notifying them three better bladder BB14 units were found to have the pigtails dislodge from the housing.\n\nWe are requesting that you immediately inspect your 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.\n\nReplacement BB14 from an unaffected lot will be available for shipping early next week.\n\nHowever, if you need to use the BB14 from the affected lot then, prior to its use, you must pull on the pigtail of\t\nthe Better-Bladder to test its bond integrity. This can be achieved by connecting a 5cc syringe to the Luer of the\t\npigtail, holding the housing and stretching the pigtail about inch. If the pigtail dislodges return the unit for\t\ncredit or replacement. After the pull test be sure to conduct the leak test described in the Instructions for Use and\ncopied below:\t\n\nCheck the seals and connections of the BB as follows: isolate the BB from the rest of the circuit by clamping off (using tubing clamps) its inlet and outlet tubing, turn stopcock S1 to connect all three ports, pull on the 10cc syringe until the pressure monitor indicates a negative pressure of approximately 100mmHg. Turn the stopcock off to the syringe but open between the BB and the transducer. Maintain that negative pressure for at least one minute. Observe the pressure indicator to assure its reading does not drift upward (from a negative value towards atmosphere) from its initial pressure reading. A change in pressure indicates that air is leaking into the housing (not the blood path) of the BB. A slight initial increase in pressure (less negative) may occur due to contraction of the components. If the pressure continues to drift upward (less negative), you have a leak. Ensure that all air- filled connect", "product_quantity": "147 units", "distribution_pattern": "US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.", "openfda": { "k_number": [ "K001602", "K033714", "K812009", "K991973", "K971013", "K844367", "K930299", "K132972", "K936286", "K844366", "K984586", "K823272", "K024065", "K961836", "K872722", "K040023", "K770546", "K011864", "K842337", "K990239", "K072697", "K820727", "K895076", "K083131", "K842391", "K090534", "K031150", "K153143", "K852382", "K013526", "K821442", "K102919", "K905818", "K911790", "K843888", "K050111", "K002496", "K030726", "K930154", "K982223", "K081947", "K050195", "K112771", "K002238", "K843595", "K902631", "K033800", "K161733", "K843232", "K882720", "K834373", "K862357", "K872720", "K964908", "K915573", "K933713", "K832924", "K913692", "K936183", "K832802", "K844229", "K841175", "K941215", "K031700", "K842620", "K780517", "K981284", "K241053", "K832671", "K994389", "K890077", "K001822", "K251783", "K030449", "K870829", "K872721", "K141233", "K934763", "K781577", "K904040", "K812455", "K862920", "K841031", "K061743", "K882414", "K012942", "K935717", "K883923", "K936003", "K091062", "K920312", "K131103", "K802890", "K033641", "K981628", "K170583", "K871775", "K082082", "K953821", "K803059", "K972017", "K823205", "K790635", "K854841", "K061527", "K964973", "K980935", "K022281", "K003551", "K223361", "K833479", "K980786", "K984456", "K974155", "K090690", "K092315", "K841079", "K151110", "K903632", "K813268", "K842711", "K883345", "K872719", "K864895", "K911876", "K993001", "K945065", "K893705", "K933481", "K760823", "K884872", "K896414", "K851401", "K926250", "K021287", "K132166", "K141432", "K982136", "K915737", "K894664", "K872378", "K893711", "K971669", "K920178", "K971105", "K812008", "K913915", "K070605", "K964907", "K122914", "K140321", "K770036", "K051606", "K882380", "K934847", "K851376", "K895356", "K841938", "K873423", "K070839", "K100507", "K802119", "K992599", "K920774", "K913956", "K925046", "K831966", "K955046", "K241206" ], "registration_number": [ "9617601", "3044156918", "3009746061", "1047843", "9681834", "3010084488", "2029275", "3015136750", "1124841", "1718850", "1724474", "3007829657", "3011554160", "1319639", "2184009", "3030125051", "3003661577", "9680841", "3005941719", "3004548776", "3003752502", "9612051", "3019807891", "2011171", "1643817", "3004080795", "3008307705", "1625519", "8010026", "1928237", "3002806603", "3016746283" ], "fei_number": [ "3044156918", "3009746061", "1047843", "2828", "1000138054", "3002534070", "3000204839", "3010084488", "3015136750", "3002808327", "1718850", "3003094851", "3007829657", "3011554160", "3002807111", "3030125051", "1000116158", "3003661577", "1000306431", "3004548776", "3003752502", "3019807891", "2011171", "3002806457", "3005426550", "1643817", "3004080795", "3008307705", "1625519", "1928237", "3002806603", "3016746283" ], "device_name": "Reservoir, Blood, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4400", "device_class": "2" } } ] }