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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 3, 2016 · Data as of Sep 19, 5:32 PM UTC

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