Class 2 Device Recall OriGen Reinforced Dual Lumen Cannula

• Date Initiated by Firm: August 21, 2018
• Create Date: October 18, 2018
• Recall Status: Terminated on July 15, 2021
• Recall Number: Z-0180-2019
• Recall Event ID: 80930
• 510(K)Number: K113869
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: 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 Information: UDI 00816203022073, Lot: N18404, N18446, N18640, N18640-1, R19208
• Recalling Firm/ Manufacturer: OriGen Biomedical, Inc.; 7000 Burleson Rd Bldg D; Austin TX 78744-3202
• For Additional Information Contact: Tonia Wilson; 512-615-7630
• Manufacturer 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
• FDA Determined Cause: 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. On 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. Consumers 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.
• Quantity in Commerce: 452
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWF