Home / Recalls / Breas Medical, Inc. / Z-0943-2022

Z-0943-2022 Class II Terminated

Recalled by Breas Medical, Inc. — North Billerica, MA

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
March 21, 2022
Termination Date
December 13, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
707 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide

Code Information

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

Other recalls by Breas Medical, Inc.

  • Z-2690-2024 Class I — Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or i (July 25, 2024)
  • Z-0405-2024 Class II — with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, (October 13, 2023)
  • Z-1382-2022 Class II — Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory (June 2, 2022)
  • Z-1352-2020 Class II — Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an acc (January 28, 2020)
  • Z-2094-2015 Class II — Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care (November 7, 2014)