{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183668", "product_res_number": "Z-0059-2021", "event_date_initiated": "2020-09-04", "event_date_created": "2020-10-06", "recall_status": "Terminated", "event_date_terminated": "2023-02-10", "res_event_number": "86417", "product_code": "BYD", "product_description": "1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.", "code_info": "SAP 109381602, Lots: 2018-09-25 2018-11-20 2018-12-10 2018-12-20 2019-01-03 2019-02-20 2019-03-20 2019-04-15 2019-05-30 2019-06-25 2019-08- 15 2019-09-05 2019- 11-05 2019-11-25  ***  SAP 109381603, Lots 2019-12-20 2020-04-30 2020-05-15 2020-05-20 2020-06-15 2020-06-30", "firm_fei_number": "3004030908", "recalling_firm": "AB ULAX", "address_1": "Merkuriusgatan 8 8 merkuriusgatan", "city": "Motala", "country": "Sweden", "reason_for_recall": "Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death.", "root_cause_description": "Process control", "action": "The firm distributed customer letters dated September 4, 2020, which informed customers of the product issue. Distributors were asked to inform customers of the recall. End users were asked to do the following:\n\n\nInventory that is Currently In-Use:\n\n1. Please evaluate any currently ventilated patient who may have such a device (any BALLARD Heat \nMoisture Exchanger (HME) 150) in their airway circuit, to determine if they belong to any of the \nimpacted product lots.\n\n2. If any of your patient(s) do have a potentially impacted device in their airway circuit, you \nmust replace such device with a commercially available alternative as soon as possible. Due to the \npotential for brain damage or death if a circuit interruption were not noticed for about 4 minutes, \nthis is a critical instruction. If, despite this instruction and at your own discretion , you elect \nstill not to do so, then you must check carefully to ensure that both ends of the device are seated \nvery firmly within the circuit; consider taping the device in place at both ends to avoid any \npotential for disconnections; and ensure that all alarms are working, monitored and addressed \nimmediately if indicated.\n\n3. Please complete the attached End-User Product Recall Response Form and return a \ncopy of the form by email to: Avanos3250@stericycle.com or fax: (888) 229-0320.\n\n4. Once the form is received, a representative will contact you to facilitate return of impacted \nBALLARD Heat Moisture Exchanger (HME) 150 .\n\n5. Avanos will manage the return of the impacted BALLARD Heat Moisture Exchanger (HME) 150.\n\nPlease respond within five (5) business days of receipt of this letter.\n\n\nInventory Already Consumed\n\n6. Please complete the attached End-User Product Recall Response Form (Attachment 1) and select the \nappropriate box to indicate that you have no inventory of impacted products.\n\n7. Please return this form to Avanos by either email: Avanos3250@stericycle.com or fax: (888)", "product_quantity": "1,484,100 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.", "openfda": { "k_number": [ "K922946", "K834292", "K953540", "K951856", "K953544", "K941436", "K945657", "K904193", "K934190", "K912335", "K941535", "K943915", "K941813", "K912699", "K903057", "K881657", "K952844", "K925622", "K881656", "K904338", "K934441", "K881308", "K933597", "K903058", "K790681", "K944194", "K953491", "K952750", "K915786", "K874597", "K945359", "K954194", "K873767", "K953580", "K953619", "K923910", "K941585", "K885313", "K912333", "K903519", "K952823", "K914336", "K821365", "K872371", "K952036", "K923865", "K950447", "K872153", "K953507", "K952845", "K946209", "K840399", "K903054", "K953620", "K912336", "K862020", "K852601", "K864095", "K942794", "K873768", "K935036", "K840398", "K902501", "K941987", "K952084", "K912700", "K912334", "K854012", "K900150", "K955008", "K844040", "K893875", "K881644" ], "registration_number": [ "", "3004050971", "3022568093", "3005587132", "9617616", "1058584", "3010889742", "3004548776", "3023464160", "3017937889", "2025182", "3010187802", "2031897", "3031369651", "3006446479", "1417592", "8043316", "3010877292", "1423662", "2025816", "3015495690", "3008770104", "3044994756", "3010957755", "9617604", "3010402691", "3005519819", "3001313714", "3006563173", "3018094310", "3012521761", "3008567544", "3021039857", "3003898360", "3043226252", "2936999", "3004365956", "3008311916", "3010321647", "9710567", "3020777588", "3014054118", "3014208300", "3011587055", "1314417", "3005515211", "9611500", "9616445", "1832562", "3012453745", "9710644", "3006534321", "3005855942", "3016734145", "3013530359", "3030733800", "3043619925", "3014747754", "8010042", "3012262567", "3006061749", "3015142701", "3012494290", "3008693658", "1824226", "3004905643", "8010485", "3004824601", "8030673", "1220479", "2529776", "3011270181", "3002907620", "8040412", "3045058049", "3013242701", "3010131137", "9680661", "3016674860", "3011503227", "2024841", "3003902312", "8021995", "3006783791", "8032044", "3008278458", "3004530184", "1000604079", "3009887154", "3004428458", "3013557562", "3007648359", "3006984712", "3010515776", "3011987967", "3030447506", "3004116032", "3013188547", "3009747810", "3004030908", "3013576541", "3010838917", "3012002722", "3008806809", "3016904853", "3016458361", "3005998497", "3010220595", "3002807267", "9616567", "3016634999", "3037918935", "3003862188", "3009171251", "1928237", "3013507143", "3021244152", "2183585", "3002806603", "3031233007", "3005012805", "3011137372", "2028807", "3010834934", "3014579161", "3003836856" ], "fei_number": [ "", "3004050971", "1000219637", "3005747797", "3022568093", "3005587132", "3010889742", "3004548776", "3023464160", "2025182", "3017937889", "3031369651", "3010187802", "3006446479", "3001104093", "1000374126", "1417592", "3010877292", "2025816", "3015495690", "3008770104", "3044994756", "3010957755", "3003949221", "3010402691", "3005519819", "3006563173", "3018094310", "3012521761", "3008567544", "3021039857", "3003898360", "3043226252", "2936999", "3009271244", "3004365956", "3008311916", "3010321647", "3020777588", "3014054118", "1000121196", "3002808696", "3014208300", "3011587055", "1314417", "3002808128", "3005515211", "1832562", "3012453745", "3006534321", "3005855942", "3016734145", "3013530359", "3030733800", "3043619925", "3003361161", "3014747754", "3012262567", "3006061749", "3015142701", "3012494290", "3008693658", "1824226", "3004905643", "3003272754", "3004824601", "1220479", "3011270181", "3002907620", "3045058049", "3002963732", "3013242701", "3010131137", "3003319165", "3016674860", "3011503227", "2024841", "3003902312", "3006783791", "3000215273", "3008278458", "3004530184", "1000604079", "3009887154", "3004428458", "3013557562", "3007648359", "3006984712", "3010515776", "3003256355", "3011987967", "3030447506", "3005749238", "3004116032", "3013188547", "3002806269", "3009747810", "3013576541", "3010838917", "3012002722", "3004030908", "3002558692", "3006363476", "3008806809", "3016904853", "3016458361", "3006759904", "3005998497", "3010220595", "3002807267", "3016634999", "3037918935", "3003862188", "1928237", "3013507143", "3004213967", "3021244152", "2183585", "3002806603", "3031233007", "3005012805", "3008581151", "3010834934", "3014579161", "3003836856", "3002807293" ], "device_name": "Condenser, Heat And Moisture (Artificial Nose)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5375", "device_class": "1" } } ] }