{ "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": 36 } }, "results": [ { "cfres_id": "129996", "product_res_number": "Z-0118-2015", "event_date_initiated": "2014-09-02", "event_date_posted": "2014-10-23", "recall_status": "Terminated", "event_date_terminated": "2016-04-25", "res_event_number": "69236", "product_code": "CAF", "k_numbers": [ "K021175" ], "product_description": "The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. \n\nThe Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. \n\nThe FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.", "code_info": "FRIWO AC/DC Adapter Model Number: GPP10;   The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer Pro family of systems: and their respective model numbers:   1) Model Number: AG-AP1040-AU; Lot Numbers: 8003140519057\t, 8003140708015\t, 8003140722089\t;  2) Model Number: AG-AP1040-EU; Lot Numbers: 800140731124\t, 8000140520074\t, 8000140520087\t, 8000140520087\t, 8000140530103\t, 8000140619082\t, 8000140620092\t, 8000140624103\t, 8000140624118\t, 8000140701104\t, 8000140702153\t, 8000140721056\t, 8000140726097\t, 8000140728100\t, 8000140728117\t, 8000140728120\t, 8000140625100,  8000140624100;  3) Model Number: AG-AP1040-UK; Lot Numbers: 8001140519067\t, 8001140624115\t, 8001140714044\t, 8001140728065\t, 8001140731125;  4) Model Number: AG-AP1040-US; Lot Numbers: 8002140520090\t, 8002140521088\t, 8002140522091\t, 8002140522093\t, 8002140523094\t, 8002140523095\t, 8002140526114\t, 8002140527096\t, 8002140603121\t, 8002140603130\t, 8002140613067\t, 8002140613068\t, 8002140616069\t, 8002140616070\t, 8002140626123\t, 8002140627124\t, 8002140627125\t, 8002140627138\t, 8002140711036\t, 8002140714042\t, 8002140721085\t, 8002140721087\t, 8002140722091\t, 8002140722092\t, 8002140722093;  5) Model Number: AG-AP1500-IN; Lot Numbers: 9948140702153;  6) Model Number: AG-AP1500-UK; Lot Numbers: 9953140801132;  7) Model Number: AG-AP1500-US; Lot Numbers: 9939140522091\t, 9939140630138;  8) Model Number: AG-AP6000(DG)-FR; Lot Numbers: 9998140611025;  9) Model Number: AG-AP6000(DG)-GE; Lot Numbers: 9997140611024;  10) Model Number: AG-AP6000(DG)-IN; Lot Numbers: 9996140728059;  11) Model Number: AG-AP6000-AU; Lot Numbers: 9915140722056\t, 9915140722089;  12) Model Number: AG-AP6000-CH; Lot Numbers: 9966140521021\t, 9966140624102;  13) Model Number: AG-AP6000-FR; Lot Numbers: 9905140521074\t, 9905140526108\t, 9905140610023\t, 9905140731072;  14) Model Number: AG-AP6000-GE; Lot Numbers: 9904140519141\t, 9904140520089\t, 9904140626100\t, 9904140702149\t, 9904140726097;  15) Model Number: AG-AP6000-IN; Lot Numbers: 9913140520026\t, 9913140526077\t, 9913140526102\t, 9913140603083\t, 9913140609009\t, 9913140617074\t, 9913140624117\t, 9913140703160\t, 9913140703160\t, 9913140703164\t, 9913140704022\t, 9913140709028\t, 9913140709029\t, 9913140711152\t, 9913140721008\t, 9913140721057\t, 9913140721078\t, 9913140728104\t, 9913140728111\t, 9913140801129\t, 9913140805137\t, 9913140604097,  9913140603097\t, 9913140609129,  9913140603129,  9913140724004,  9913140725004,  9913140729004,  9913140728004,  9913140723004;  16) Model Number: AG-AP6000-IT; Lot Numbers: 9906140515023\t, 9906140710033;  17) Model Number: AG-AP6000-NO; Lot Numbers: 9916140519058;  18) Model Number: AG-AP6000-RU; Lot Numbers: 9968140704166,  9968140721077;  19) Model Number: AG-AP6000-SP; Lot Numbers: 9907140519028\t, 9907140730097;  20) Model Number: AG-AP6000-SW; Lot Numbers: 9927140607011;  21) Model Number: AG-AP6000-UK; Lot Numbers: 9903140520025\t, 9903140526111\t, 9903140722056\t, 9903140728098;  22) Model Number: AG-AP6000-US; Lot Numbers: 9902140616065\t, 9902140616067\t, 9902140617070", "firm_fei_number": "3003399703", "recalling_firm": "Aerogen Ltd.", "address_1": "Galway Business Park", "city": "Dangan Galway", "country": "Ireland", "reason_for_recall": "Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.", "root_cause_description": "Nonconforming Material/Component", "action": "URGENT FIELD SAFETY NOTICE letters dated September 2, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) compare their power adapter date codes against those found in the letter as being subject to this recall; 2) until new power adapters are received, customers may continue to use the recalled power adapters if the customer inspects each power adapter prior to use and finds that there is no evidence of damage or separation of the housing and unplug the adapter after each use; and, 3) contact the Aerogen or appropriate Aerogen sales partner immediately so that the power adapter can be replaced free of charge. The letter further requests that the recall notification be forwarded to any parties that may have received the recalled power adapters. Customers with questions can contact Aerogen at 866-423-76436.", "product_quantity": "2,421 power adapters", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K952326", "K883964", "K913095", "K233553", "K192724", "K020944", "K926280", "K990185", "K021742", "K780119", "K800083", "K980024", "K121770", "K053605", "K032170", "K921273", "K923888", "K061381", "K080230", "K230379", "K103635", "K960854", "K981249", "K772222", "K952893", "K202171", "K772072", "K090307", "K050183", "K914836", "K133360", "K913096", "K800023", "K896536", "K981944", "K993492", "K834077", 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