Reported Mar 7, 2018 · Terminated

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is…

Terumo Medical Corporation

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: Terumo Medical Corporation · 950 Elkton Blvd · Elkton, MD · 21921-5322

Is this the product you have?

  • Destination Guiding Sheath catheter introducer
  • Catalog NumberRSR06
  • Product UsageThe Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries
Lot codes and dates
  • LotVK09
  • Expiration Date31-Jan-2020
Amount recalled
33

Why it was recalled

The tucking depth feature of this catheter introducer is marginally outside the upper specification.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 31, 2018 · Data as of Sep 19, 5:22 PM UTC

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