{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167608", "product_res_number": "Z-0269-2019", "event_date_initiated": "2015-03-30", "event_date_posted": "2018-11-07", "recall_status": "Terminated", "event_date_terminated": "2024-03-01", "res_event_number": "81164", "product_code": "DWF", "k_numbers": [ "K113869" ], "product_description": "REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 \n\nProduct Usage:\nThe OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.", "code_info": "Product Code\tUDI\t Lot VV19F\t 00816203022097\tN18394", "firm_fei_number": "1000160256", "recalling_firm": "OriGen Biomedical, Inc.", "address_1": "7000 Burleson Rd Bldg D 7000 Burleson Rd", "address_2": "Bldg D", "city": "Austin", "state": "TX", "postal_code": "78744-3202", "additional_info_contact": "Tonia Wilson\n512-615-7630", "reason_for_recall": "Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage", "root_cause_description": "Mixed-up of materials/components", "action": "On April 1, 2015 the firm sent an MEDICAL DEVICE MARKET WITHDRAWAL to customers/distributors via email to inform them the catheters may start to show signs of failure at the junction of the clear extension tube and blue hub connection that can be recognized by air entrainment or blood leakage. If the preliminary failure is identified, the catheter should be replaced immediately. Serious injuries could occur due to the failure mode. The customers are instructed to discontinue use of all products from the affected lot and to return any unused products immediately and to complete and return the acknowledgement and receipt form even if the customer does not currently have products in its inventory.\n\nThe firm is conducting an investigation to determine root cause of the failure and will notify the customers when the investigation has been completed and when replacement products are available. If customers have any questions regarding the return of product or the status of the investigation, they can contact:\nOriGen Biomedical\nAttn: Bernie R Silvers\n7000 Burleson Road, Building D\nAustin, TX 78744\nPhone Number +1 512-474-7278", "product_quantity": "134", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI\n\nOUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom", "openfda": { "k_number": [ "K910021", "K884310", "K862190", "K032632", "K874899", "K895352", "K821316", "K143083", "K873212", "K961270", "K832475", "K092509", "K863740", "K120072", "K844138", "K883221", "K081820", "K905312", "K901074", "K863558", "K851323", "K810820", "K881072", "K860988", "K863342", "K874853", "K132995", "K062597", "K870507", "K012617", "K961245", "K150536", "K964195", "K180456", "K902394", "K802261", "K840001", "K861103", 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