Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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.

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

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 [email protected].