Reported Mar 13, 2019 · Terminated

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site…

Maquet Cardiovascular, LLC

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: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • AXIUS
  • Blower Mister Product Code/REF NumberCB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Lot codes and dates
  • Lot Numbers
    • 96255605
    • 96255607
    • 96255608
    • 96255609
    • 96255611
  • UDI20607567700745
Amount recalled
7,880 each (1,576 packs of 5)

Where it was sold

  • Nationwide

Why it was recalled

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

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 Jul 13, 2020 · Data as of Sep 19, 4:53 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.