Reported Nov 23, 2016 · Terminated

Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or…

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 Medical 28 Fr Trocar catheter
  • Sterile Model Number8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum
Lot codes and dates
  • All lot codes
Amount recalled
7043 cases (10/cs)

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

Why it was recalled

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 2018 · Data as of Sep 19, 5:22 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.