Breas Medical, Inc. Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 Christina.Joiner@breas.com Helpline +1 (855) 436-8724 Postal Address 16 Esquire Road, N. Billerica, MA 01862 Web Portal breas.com