FDAClass IIApril 20, 2022

Breas Ventilator Trolley with the Vivo 50/60/65 and recall

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

Why was Breas Ventilator Trolley with the Vivo 50/60/65 and recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Recalling firm
Breas Medical, Inc.
Quantity
707 units
Distribution
US Nationwide
Recall date
April 20, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls