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Safety Report: Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure, USA

1 month ago •source fda.gov

Recall notice

Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure photo #1

United States

Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions.

Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness such as asthma in small pediatric patients resulting in additional medical intervention (e.g., bronchodilator administration, adjustment of ventilator settings, increased duration or degree of ventilatory support and/or oxygen support).

The devices can be identified by the model name on the front panel of the device and the model and serial numbers on the back panel (“REF” and “SN”, respectively). The devices have been distributed nationwide in the U.S. to Durable Medical Equipment providers (“DME’s”), distributors, and facilities.

The product recalled is Vivo 45 LS (US Version) Ventilator, UDI-DI D*****, F*****, K*****, M*****, N01*** - N270030. Manufacturing dates up to and including “240530” (May 30th, 2024). The devices subject to this correction were manufactured from February 4, 2021 to July 1, 2024, and distributed from February 12, 2021 to July 24, 2024.

End users and other recipients of the Vivo 45 LS device in the U.S. should contact the company that provided the device or Breas Medical for further information regarding the necessary corrective measures if needed.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Breas Medical
Brand name: Breas
Product recalled: Vivo 45 LS (US Version) Ventilator
Reason of the recall: Potential for short term elevated levels of formaldehyde exposure
FDA Recall date: August 09, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/breas-medical-issues-voluntary-us-nationwide-urgent-medical-device-correction-in-vivo-45-ls-ventilator

#medicaldevices #recall #us

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