Z-0021-2018 Class I Terminated
FDA device recall Z-0021-2018 was initiated by OriGen Biomedical, Inc. on August 2, 2017 and is designated Class I. 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 p… The recall status is terminated (terminated February 29, 2024). Affected quantity: 180 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- August 2, 2017
- Termination Date
- February 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 units
Product 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 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).
Distribution Pattern
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.
Code Information
Lot Numbers: N18487, N18487-1