Reported Oct 30, 2013 · Terminated

Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

Merit Medical Systems, 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: Merit Medical Systems, Inc. · 1600 West Merit Parkway · South Jordan, UT · 84095

Is this the product you have?

  • Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Lot codes and dates
  • Part Number/Lot Number
    • 7560-43/I663860
    • 7560-43/I663861
    • 7560-G3/I664519 and 7560-G3/I666388
Amount recalled
200

Where it was sold

Why it was recalled

4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

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 Jan 3, 2014 · Data as of Sep 19, 4:47 PM UTC

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