Reported Nov 14, 2018 · Terminated
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The 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 Bldg D · Austin, TX · 78744-3202
Is this the product you have?
REF VV19F Reinforced Dual Lumen Cannula19FrSterile EO
- DISPOSABLEDO
- NOT RE-USE CE 0473 Product UsageThe OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less
- Lot codes and dates
- Product Code UDI Lot VV19F 00816203022097 N18394
- Amount recalled
- 134
Where it was sold
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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