Reported Oct 21, 2015 · Terminated

Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access…

Concentric Medical Inc.

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: Concentric Medical Inc · 301 E Evelyn Ave · Mountain View, CA · 94041-1530

Is this the product you have?

  • Distal Access Catheters - 044 - 115 cmFinished Good Number 90960-001 / REF 90960
  • CardiologyThe Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems
Lot codes and dates
  • Lot no. 37603
  • Expiration dateSeptember 2016
Amount recalled
1

Where it was sold

Why it was recalled

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

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 Oct 9, 2015 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.