Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo… recallZ-0943-2022 · Breas Medical, Inc. · initiated Mar 21, 2022

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Breas Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Process control

What the company is doing

Breas Medical issued recall information via telephone followed by Urgent Medical Device Recall letter to Distributors/End Users via email on 3/21/22 via telephone.. Letter state reason for recall, health risk and action to take: Breas Medical s solution is to provide Inspect and Repair Kits (REF 008591) to all those potentially affected by this notice. The Inspect and Repair Kits are used to inspect the Trolley to determine if remedial action is required, and to replace the defective part if needed. We will send you enough Inspect and Repair Kits (REF 008591)s for all trolleys in your possession. " We (the Customer) will identify Breas Ventilator Trolleys (REF 007384) delivered between June 11th, 2020, and December 3rd, 2021. " Breas will provide us with the corresponding number of Inspect and Repair Kits (REF 008591). " We will inspect the swivel assembly and complete the enclosed form to indicate whether the trolley contained the necessary washer and no further action is needed, or if the washer was missing and the swivel assembly was replaced by the new one. " We will scrap the replaced swivel assembly. e kindly ask you to acknowledge receipt of this Field Safety Notice together with your choice to remedy the issue using attached reply form Trolley Field Safety Notice Distributor/Customer Reply Form with Option Selection . Contact Information Email [email protected] Helpline +1 (855) 436-8724 Postal Address 16 Esquire Road, N. Billerica, MA 01862 Web Portal breas.com

Recall details

Recall number: Z-0943-2022
Status: Terminated
Initiated by the company: Mar 21, 2022
Recalling firm: Breas Medical, Inc.
Quantity: 707 units
Product code: CBK
Distribution: US Nationwide

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Ventilator Trolley 007384
Breas Medical AB · Stand, Infusion
1 recall1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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