Reported Apr 29, 2015 · Terminated
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen…
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 · Austin, TX · 78744-3202
Is this the product you have?
- OriGen BIOMEDICAL VV13F Reinforced
- Dual Lumen Catheter STERILE DISPOSABLEDO
- NOT RE-USE Manufactured byOriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less
- Lot codes and dates
- Lot N18549
- Amount recalled
- 51 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
Using this product could cause serious injury, illness or death — stop using it now.
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