Z-0943-2022 Class II Terminated
FDA device recall Z-0943-2022 was initiated by Breas Medical, Inc. on March 21, 2022 and is designated Class II. 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 cau… The recall status is terminated (terminated December 13, 2024). Affected quantity: 707 units.
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