The Recall Desk
HighFDA (Devices)·Z-1352-2020·Announced 2020-03-04

Breas Medical Recalls Vivo Ventilator Protective Covers Due to Obstruction Risk

Breas Medical is recalling 629 Vivo ventilator protective covers because the design may obstruct the exhalation valve control pressure tube.

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: The recall involves a medical device where a mechanical obstruction could impair ventilator function, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Breas Medical, Inc. is recalling 629 units of the Protective Cover Vivo 55/65 (Part No. 006344). This accessory is intended for the Vivo 50, Vivo 55, Vivo 60, and Vivo 65 ventilators to provide protection during transportation and in various care environments. The covers were distributed worldwide and in specific US states between January 11, 2018, and December 17, 2019.

The recall is being issued because the outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. This obstruction could interfere with the proper function of the ventilator's pressure control system. The covers do not have lot numbers.

Users should stop using the protective cover immediately and contact Breas Medical for instructions on how to proceed. The device should not be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator, as per standard usage guidelines.

The recalled product

Product
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilat
Manufacturer
Breas Medical, Inc.
Category
Medical Device — Ventilator Accessory
Hazard
Affected units
629

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 (2)

  • The cover does not have a lot number
  • these covers were distributed between 01/11/2018 and 12/17/2019

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Related recalls

Same manufacturer · Breas Medical, Inc.

See all →