Recall Z-0021-2018 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
OriGen Biomedical, Inc.
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
| Date | Oct 20, 2017 (initiated Aug 2, 2017) |
| Status | Terminated |
| Reason | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss). |
| Root cause | Under Investigation by firm |
| Action | The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit. |
| Quantity | 180 units |
| Distribution | US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates. |
| 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 |