Reported Jul 2, 2014 · Terminated

Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or…

Nellcor Puritan Bennett Inc. (dba Covidien LP)

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: Nellcor Puritan Bennett Inc. (dba Covidien LP) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214

Is this the product you have?

  • Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
Lot codes and dates
  • serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.
Amount recalled
104

Where it was sold

Why it was recalled

Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.

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 Aug 22, 2016 · Data as of Sep 19, 4:45 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.