The OriGen Reinforced Dual Lumen catheter recall
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…
Why was The OriGen Reinforced Dual Lumen catheter recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: N18487, N18487-1
- 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…
- Recalling firm
- OriGen Biomedical, Inc.
- 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.
- Recall date
- November 1, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)