{ "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": "99387", "product_res_number": "Z-0108-2012", "event_date_initiated": "2011-03-25", "event_date_posted": "2011-10-26", "recall_status": "Terminated", "event_date_terminated": "2011-10-26", "res_event_number": "58454", "product_code": "CCQ", "k_numbers": [ "K870027" ], "product_description": "Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free\nSalter Labs, Arvin, CA 93203\n\nIntended usage: respiratory therapy.", "code_info": "Product code: 8924-7-50, Lot 022811", "firm_fei_number": "1314417", "recalling_firm": "Salter Laboratories, Division of Regulatory Affairs", "address_1": "100 Sycamore Rd", "city": "Arvin", "state": "CA", "postal_code": "93203-2300", "additional_info_contact": "Gus Bock\n661-854-6871", "reason_for_recall": "A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.", "root_cause_description": "Equipment maintenance", "action": "The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an \"URGENT PRODUCT RECALL\" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690.\n\nShould you have any questions, please contact Salter Labs at 1-800-235-4203.", "product_quantity": "9000 all varieties", "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.", "openfda": { "k_number": [ "K811404", "K854551", "K854520", "K875024", "K895115", "K853071", "K841991", "K802281", "K842988", "K961455", "K851525", "K823423", "K841321", "K896070", "K873477", "K972397", "K860875", "K874513", "K895592", "K870027", "K892117", "K842192", "K894215", "K832037", "K894244", "K872315", "K964956", "K854550", "K850926", "K822625", "K841989", "K922033", "K870332", "K810343", "K894441", "K871151", "K961894", "K894555", "K843102", "K781394", 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