{ "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": "74064", "product_res_number": "Z-0319-2009", "event_date_initiated": "2008-10-07", "event_date_posted": "2008-12-05", "recall_status": "Terminated", "event_date_terminated": "2008-12-08", "res_event_number": "49713", "product_code": "BSZ", "k_numbers": [ "K080175" ], "product_description": "AS3000 Anesthesia Delivery System. Datascope Patient Monitoring;\nA Mindray Global Company.\n\nThe AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.", "code_info": "Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.", "firm_fei_number": "2221819", "recalling_firm": "Mindray DS USA, Inc., dba Datascope Patient Monitoring", "address_1": "800 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430", "additional_info_contact": "Thomas W. Barford\n201-995-8391", "reason_for_recall": "Two issues have been identified with the AS3000 unit.\n1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit.\n2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate", "root_cause_description": "Component design/selection", "action": "Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.", "product_quantity": "2 units", "distribution_pattern": "Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.", "openfda": { "k_number": [ "K170872", "K790456", "K042607", "K770554", "K112114", "K993410", "K032803", "K854213", "K151570", "K921742", "K800801", "K101439", "K122445", "K973896", "K844421", "K903135", "K965160", "K830159", "K120075", "K072884", "K981845", "K000995", "K923519", "K791530", "K103035", "K884879", "K030939", "K945722", "K935546", "K771479", "K971030", "K963481", "K003251", "K903991", "K131945", "K803052", "K191027", "K802591", "K974193", "K171292", "K841370", "K882489", "K760228", "K893780", "K973971", "K083098", "K050626", "K830680", "K033026", "K041622", "K060193", "K071142", "K000706", "K963994", "K850648", "K945234", "K031400", "K853435", "K042419", "K901119", "K251352", "K844849", "K970163", "K853139", "K930492", "K102389", "K844563", "K890410", "K901713", "K132530", "K864590", "K062388", "K051629", "K900329", "K133958", "K011404", "K201957", "K844008", "K971425", "K864806", "K213867", "K973949", "K933285", "K042154", "K252746", "K062155", "K132903", "K864589", "K102471", "K946127", "K983635", "K905635", "K822218", "K001727", "K833335", "K253330", "K980553", "K830161", "K863207", "K945463", "K833147", "K110213", "K884991", "K982137", "K884802", "K050055", "K131790", "K894309", "K081844", "K900937", "K122063", "K902962", "K872178", "K123125", "K864447", "K801100", "K830160", "K003579", "K000859", "K061102", "K052335", "K071097", "K033498", "K230931", "K040743", "K913791", "K771057", "K992421", "K923172", "K001488", "K113633", "K833151", "K080175", "K151954", "K781492", "K801102", "K022031", "K771989", "K092864", "K972848", "K081447", "K930351", "K841274", "K862831", "K061609", "K171311", "K142552", "K003663", "K852175", "K143530", "K172045", "K965041", "K072420", "K140264", "K864644", "K041430", "K042086", "K083413", "K123211", "K973985", "K133886", "K081941", "K801103", "K840356", "K090892", "K901117", "K160665", "K050883", "K934669", "K001315", "K102182", "K073707", "K030624", "K012446", "K920944", "K001988", "K050676", "K861170", "K900328", "K851621", "K862085", "K855022", "K090233", "K844012", "K925580", "K112722", "K981530", "K010613", "K875350" ], "registration_number": [ "", "3022543477", "3003589956", "3014579161", "3005783425", "3010157426", "2221819", "3001104093", "8043316", "3035111606", "3013188547", "9617604", "9710602", "1066270", "3021559257", "9610531", "3009129579", "3009156722", "1054713", "2020813", "9611295", "3016618143", "1530958", "8010042", "2518157", "1066427", "2112667", "1000122786", "3005803793", "3007603826", "3000126629", "3007238566", "3010703925", "9611500" ], "fei_number": [ "", "3022543477", "3002808128", "3003589956", "3002807907", "3014579161", "3005783425", "3010157426", "2221819", "3001104093", "3035111606", "3000957797", "3013188547", "1000639866", "3007513035", "3003513129", "3021559257", "3009129579", "3009156722", "3023530182", "2020813", "3003319165", "3016618143", "3002807992", "2518157", "2112667", "1000122786", "3005803793", "3007603826", "3000126629", "3007238566", "3002558692", "1000114111", "3010703925" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }