Breas Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1352-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.

Product Classification:

Class II

Date Initiated: January 28, 2020

Date Posted: March 4, 2020

Recall Number: Z-1352-2020

Event ID: 84828

Reason for Recall:

The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.

Status: Terminated

Product Quantity: 629

Code Information:

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

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AR, CA, FL, GA, IA, IL, KS, MA, MI, MO, NJ, NY, OH, PR, SC, TX, VA, WI and countries distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated