Recall Z-0943-2022— Breas Medical, Inc.

Name: FDA recall Z-0943-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-21

Class II · Terminated

Class II FDA medical device recall by Breas Medical, Inc., initiated 2022-03-21, terminated 2024-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384. Reason: 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.

Recalling firm: Breas Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Terminated: 2024-12-13
Firm location: North Billerica, MA, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.