Recall Z-1456-2015 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
OriGen Biomedical, Inc.
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter 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 of six hours or less.
| Date | Apr 23, 2015 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | 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 | Mixed-up of materials/components |
| Action | The firm, OriGen, sent an "URGENT; MEDICAL DEVICE RECALL" letter dated 3/30/2015 and response form to all consignees via e-mail. The conisgnees were notified on 3/31/15 and 4/1/15. The recalling firm also posted a recall notification on the ELSO website, which is a public site mainly used by professionals within the ECMO community and press release dated 4/15/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to discontinue use of all OriGen W13F Reinforced Dual Lumen ECMO Catheters from the lot; immediately return any unused product t |
| Quantity | 51 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands. |
| 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 |