FDA Enforcement
Class I
Terminated
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.
Recall: Z-0021-2018
·
Reported November 1, 2017
Enforcement
- Recall Number
- Z-0021-2018
- Event ID
- 78033
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- OriGen Biomedical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2017
- Initiation Date
- August 2, 2017
- Classification Date
- October 20, 2017
- Termination Date
- February 29, 2024
- Address
- 7000 Burleson Rd Bldg D, N/A, Austin, TX, 78744-3202, United States
Description
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.
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).
Code Info
Lot Numbers: N18487, N18487-1
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.
Quantity
180 units