Z-0943-2022Class II

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

Name: Z-0943-2022 Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Creator: Breas Medical, Inc.
Published: 2022-03-21
License: https://open.fda.gov/license/

Breas Medical AB / initiated 2022-03-21 / Terminated / root cause: manufacturing process

FDA source

Breas Medical, Inc. began a recall of Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 on 2022-03-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0943-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Posted: 2022-04-15
Terminated: 2024-12-13
Recalling firm: Breas Medical AB
Product: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Product code: CBK Ventilator, Continuous, Facility Use
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 707 units
Distribution: US Nationwide
Product codes and lots: Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0943-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0943-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code CBK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)