The Recall Desk
HighFDA (Devices)·Z-0943-2022·Announced 2022-04-20

Ventilator trolley mounting brackets can detach and cause device to fall

The mounting brackets on Breas Ventilator Trolleys can become detached, allowing ventilators to fall. This poses an injury risk to people near the equipment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of medical equipment with potential for patient injury from a falling ventilator. However, no illnesses or injuries have been reported, and the rubric limits theoretical hazards without reported harm to at most High (3).

Plain-English summary

Breas Medical, Inc. is recalling Breas Ventilator Trolleys (Article No. 007384) designed for use with Vivo 50/60/65 and Vivo 45LS ventilator models. The recall affects 707 units that were delivered between June 11, 2020, and December 3, 2021.

The ventilator mounting brackets on these trolleys can become detached. When this occurs, the ventilator may fall from the trolley and cause injury to individuals in the immediate proximity of the equipment.

This recall applies nationwide. Affected trolleys can be identified by their UDI: 07321820073849.

The recalled product

Product
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Manufacturer
Breas Medical, Inc.
Category
Medical Device — Ventilator Support Equipment
Hazard
Affected units
707

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Trolleys delivered between June 11th
  • 2020
  • and December 3rd
  • 2021. UDI: 07321820073849

Distribution

Distributed nationwide across the United States.

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