Recall Z-0021-2018
OriGen Biomedical, Inc. · initiated August 2, 2017
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: Lot Numbers: N18487, N18487-1
Reason for recall
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).
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0021-2018
- Initiated
- August 2, 2017
- Posted by FDA
- October 20, 2017
- Terminated
- February 29, 2024
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- 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.
- Recalling firm
- OriGen Biomedical, Inc., Austin, TX