{ "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": "35110", "product_res_number": "Z-0177-05", "event_date_initiated": "2004-09-07", "event_date_posted": "2004-11-05", "recall_status": "Terminated", "event_date_terminated": "2005-08-24", "res_event_number": "30068", "product_code": "CAF", "k_numbers": [ "K032849" ], "product_description": "Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): \n\nModel 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual;\n\nModel 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual;\n\nModel 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual;\n\nModel 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual;\n\nModel 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual;\n\nModel 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual.\n\n7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual;\n\n7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.", "code_info": "040120, 040127, 040129, 040130, 040201, 040202, 040203, 040205, 040209, 040210, 040216, 040219, 040227, 040301, 040303, 040305, 040311, 040317, 040406, 040407, 040415, 040427, 040421, 040428, 040506, 040721, 040723, 040726, 040730, 080504, 080904, 081104, 081604, 081704, 081904, 082004, 082304, 082504, 082704, 083004, 083104, 080304", "firm_fei_number": "1931654", "recalling_firm": "Medical Industries America Inc", "address_1": "2636 289th Pl", "city": "Adel", "state": "IA", "postal_code": "50003-8021", "additional_info_contact": "Dan Bunting\n515-993-5001 Ext. 214", "reason_for_recall": "The nebulizer can either fail or provide a low flow (partial dose) of medication", "root_cause_description": "Other", "action": "The recalling firm initiated their action via telephone on 9/7/04 to the care providers to inform them of the product problem and that they would soon be receiving additional information about the recall. Between 9/24-28/04, the firm issued letters to their care providers with specific instructions as to how to decide what individuals would or would not need a backup generator in their possession. They were also instructed to pass the information onto the end user. On 10/1/04, the firm called the care providers and subsequently issued second letters or postcards to them to correct the toll free number that had been misprinted on the literature and letter.", "product_quantity": "17,464 units", "distribution_pattern": "Distribution was made to home health care providers and pharmacies nationwide. \n\nForeign distribution was made to Italy, Greece, France, Poland, Japan, Hong Kong, Argentina, Australia, Israel, and Singapore.", "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", "K963917", "K980074", "K923698", "K170916", "K070498", "K192971", "K781542", "K922187", 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