{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Waltham", "state": "MA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "74241", "recalling_firm": "Fresenius Medical Care Renal Therapies Group, LLC", "address_1": "920 Winter St", "address_2": "N/A", "postal_code": "02451-1521", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Distributed US (nationwide)", "recall_number": "Z-2044-2016", "product_description": "Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX", "product_quantity": "875 units", "reason_for_recall": "Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.", "recall_initiation_date": "20160524", "center_classification_date": "20160621", "termination_date": "20210430", "report_date": "20160629", "code_info": "S/N: 1C01M140014 1C01M140015 1C01M140020 1C01M140046 1C01M140050 1C01M140055 1C01M140063 1C01M140071 1C01M140075 1C01M140090 1C31M140024 1C31M140025 1C31M140026 1C31M140027 1C31M140028 1C31M140036 1C31M140037 1C31M140058 1C32M140015 1C32M140018 1C32M140019 1C32M140049 1C32M140050 1C32M140051 1C32M140061 1C40M140081 1C40M140086 1C40M140087 1C40M140088 1C41M140001 1C41M140002 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