Reported Apr 20, 2022 · Terminated

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Breas Medical, Inc.

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: Breas Medical, Inc. · 16 Esquire Rd · North Billerica, MA · 01862-2527

Is this the product you have?

  • Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Lot codes and dates
    • Trolleys delivered between June 11th
    • 2020
    • and December 3rd
    • 2021
  • UDI07321820073849
Amount recalled
707 units

Where it was sold

  • Nationwide

Why it was recalled

Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

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 Dec 13, 2024 · Data as of Sep 19, 4:56 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.