{ "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": "167037", "product_res_number": "Z-0180-2019", "event_date_initiated": "2018-08-21", "event_date_created": "2018-10-18", "recall_status": "Terminated", "event_date_terminated": "2021-07-15", "res_event_number": "80930", "product_code": "DWF", "k_numbers": [ "K113869" ], "product_description": "Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO\n\nIndications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.", "code_info": "UDI 00816203022073, Lot: N18404, N18446, N18640, N18640-1, R19208", "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": "These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip", "root_cause_description": "Component design/selection", "action": "On 08/21/18, the firm, OriGen, emailed a recall notice dated 8/17/2018 to customers informing them of a nationwide recall of RDLC ECMO catheters. Customers were advised to return affected product to the firm. Customers with additional questions were advised to call 1-800-233-9014 or 1-512-474-7278. The firm also sent customers Technical Bulletin (TB) 1411 - Revision Feb 2018, Subject: Radiopacity of the Reinforced Dual Lumen Catheter (RDLC), Date: July 2015, and an Acknowledgment Receipt form to complete and return.\n\nOn 09/12/18, the firm, Origen, sent another recall notice, dated 9/12/2018 which included additional affected lot numbers. TB1411 was sent to customers three additional times (Version/Customer Notification Date): R00/11/10/14, R01/07/22/15, and Revision Feb 2018/02/12/18.\n\nConsumers with questions may contact the company via telephone at 1-800 233 9014 between the hours of 08:00 and 16:30 (CDT). Customers outside the USA may contact OriGen at +1.512.474.7278. Customers may also contact the company via e-mail at ecmo@origen.com.", "product_quantity": "452", "distribution_pattern": "Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.", "openfda": { "k_number": [ "K250937", "K880779", "K881352", "K971023", "K955121", "K883412", "K140165", "K834134", "K152161", "K901074", "K880421", "K110980", "K171979", "K970914", "K802261", "K890024", "K020693", "K081820", "K033264", "K801397", "K990772", "K880180", "K840914", "K090878", "K023880", "K131269", "K854640", "K001371", "K010737", "K062597", "K844140", "K043179", "K801396", "K964195", "K832124", "K895352", 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