Recall Z-0180-2019 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
OriGen Biomedical, Inc.
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.
| Date | Aug 21, 2018 |
| Status | Terminated |
| Reason | 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 | 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 wh |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113869 | ORIGEN REINFORCED DUAL LUMEN CATHETER Origen Biomedical, Inc., Jul 26, 2012 |