Reported Feb 21, 2018 · Terminated

Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial…

Arrow International 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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607

Is this the product you have?

  • Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Lot codes and dates
  • Lot Numbers1) 23F16H0859 & 2) 23F16J0547

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

Needle supplier indicated the presence of loose polypropylene foreign matter above release 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 Sep 14, 2018 · Data as of Sep 19, 5:21 PM UTC

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