Reported Feb 22, 2017 · Terminated

Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

Atrium 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: Atrium Medical Corporation · 5 Wentworth Dr · Hudson, NH · 03051-4929

Is this the product you have?

  • Atrium PVC 10 Fr
  • Straight Thoracic Catheter Code Number8010
Lot codes and dates
  • All Lot Numbers With Expiration Date Prior To December 2019
Amount recalled
1394 cases (10/case)

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide

Why it was recalled

Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)

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 Nov 3, 2020 · Data as of Sep 19, 4:47 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.