{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "90493", "product_res_number": "Z-0308-2012", "event_date_initiated": "2010-03-31", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-01-05", "res_event_number": "55294", "product_code": "CAH", "k_numbers": [ "K063526" ], "product_description": "ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients\nFor use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.", "code_info": "Lot numbers: 551278, 551311, 551355, 551425, 551432, 551452, 551635, 551658, 551699, 551704, 551727, 551732, 551746, 551800, 551879, 551905, 551954 and 552095.", "firm_fei_number": "3020614", "recalling_firm": "A M Systems Inc", "address_1": "131 Business Park Loop", "address_2": "P.O. Box 850", "city": "Sequim", "state": "WA", "postal_code": "98382-0850", "additional_info_contact": "Robert Thompson\n360-683-8300", "reason_for_recall": "Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.", "root_cause_description": "Nonconforming Material/Component", "action": "A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer.\n\nCustomers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession.\n\nPlease call 360.683.8300, if you have any questions or concerns.", "product_quantity": "37800", "distribution_pattern": "Worldwide Distribution -- USA ( nationwide) including the states of AZ, CA, FL, KY, MA, MI, NC, OH, OR, and WI., and the countries Canada, Mexico, and Taiwan.", "openfda": { "k_number": [ "K063526", "K983610", "K011132", "K802914", "K925388", "K092451", "K871366", "K890035", "K964979", "K941676", "K151498", "K840205", "K961838", "K032322", "K934272", "K923661", "K884465", "K132709", "K811546", "K230483", "K893030", "K030071", "K802763", "K973238", "K061426", "K912577", "K121382", "K930816", "K223258", "K013089", "K964204", "K791773", "K833269", "K770375", "K930760", "K890346", "K780535", "K841236", "K210352", "K965016", "K911738", "K130664", "K792097", "K900990", "K812075", "K982127", 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