{ "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": "160803", "product_res_number": "Z-0407-2018", "event_date_initiated": "2017-10-09", "event_date_created": "2018-01-24", "recall_status": "Terminated", "event_date_terminated": "2023-09-15", "res_event_number": "78883", "product_code": "CAW", "k_numbers": [ "K080391" ], "product_description": "PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S", "code_info": "UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers", "firm_fei_number": "3000719543", "recalling_firm": "Inovo, Inc", "address_1": "401 Leonard Blvd N", "city": "Lehigh Acres", "state": "FL", "postal_code": "33971-6302", "reason_for_recall": "Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS\ndemonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output\noxygen below the published specification).", "root_cause_description": "Under Investigation by firm", "action": "The firm initiated their recall by letter on 10/09/2017. The letter stated the following:\n\"Actions to be Taken:\nBased on our distribution records, your firm has received one or more Pure Stationary Oxygen Concentrators. We respectfully request that you take the following actions: \n1. Contact all patients and customers that currently have Pure Stationary Oxygen Concentrators in their homes or facilities and inform them of this recall. Retrieve the oxygen concentrators from their homes or facilities.\n\n2. Destroy all Pure Stationary Oxygen Concentrator(s) in accordance with the following steps: \na. Assure that the unit is not plugged into an electrical outlet.\nb. Cut the power cord of each oxygen concentrator.\nc. Take a digital photo of each oxygen concentrator that depicts both the power cord and the serial number of the depicted unit. Note that the serial number is located on a label on the back of the unit.\nd. Dispose of the oxygen concentrator in accordance with local ordinances.\ne. Record the serial number of each unit that is destroyed, sign and date the enclosed Recall Return Response Card.\n\n3. Email or fax the completed response form and photos documenting destruction to:\nEmail: lnovo4209@stericycle.com\nFax: 1-877-497-2559\n\n4. Sales of the Pure Stationary Oxygen Concentrator have been discontinued. Pure Stationary Oxygen Concentrators which have been destroyed will be replaced with a DeVilbiss 525DS Oxygen Concentrator in order to minimize any interruption in patient's supplemental oxygen therapy.\n\n5. Pure Concentrators that have been returned to lnovo for repair will not be returned and will be replaced with a DeVilbiss 525DS Oxygen Concentrator.\n\nOther Information:\nShould you require any additional information about this recall action, please call 1-888-679-5132, Monday-Friday 8am-Spm Eastern.\"", "product_quantity": "13,140 units", "distribution_pattern": "worldwide", "openfda": { "k_number": [ "K971129", "K933081", "K780020", "K223379", "K854509", "K071397", "K012037", "K924818", "K211056", "K924565", "K982243", "K912794", "K242736", "K884018", "K913327", "K252399", "K030920", "K792149", "K915381", "K213210", "K041664", "K251607", "K852144", "K162433", "K063454", "K771761", "K821393", "K890150", "K904639", "K134023", "K991569", "K120785", "K810411", "K791043", "K101154", "K883837", "K850253", "K924152", "K222920", "K240561", "K851438", "K071608", "K210371", "K854374", "K833500", "K884563", "K864045", "K941145", "K860060", "K053230", "K100920", "K935370", "K780862", "K190304", 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"medical_specialty_description": "Anesthesiology", "regulation_number": "868.5440", "device_class": "2" } } ] }