Reported Mar 28, 2018 · Terminated
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated…
Vascular Insights, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Vascular Insights, LLC · 1 Pine Hill Dr Ste 100 · Quincy, MA · 02169-7485
Is this the product you have?
- ClariVein IC infusion catheter
- Model Number65-018-E4S
- Product UsageThe ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature
- Lot codes and dates
- Lot numberBM651403017I
- Amount recalled
- 928
Where it was sold
Why it was recalled
Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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