Reported Nov 1, 2017 · Terminated
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of…
OriGen Biomedical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OriGen Biomedical, Inc. · 7000 Burleson Rd Bldg D · Austin, TX · 78744-3202
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
N18487N18487-1
- Lot Numbers
- Amount recalled
- 180 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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