Reported Sep 28, 2022 · Ongoing

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

Covidien 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: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

    • Puritan Bennett 560 Ventilator
    • PB560
    • CFN 4096600
Lot codes and dates
  • UDI-DI10884521196377 U.S
  • Serial Numbers40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
Amount recalled
5 US

Where it was sold

Why it was recalled

Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

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

Data as of Sep 19, 3:25 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.