Class 2 Device Recall Breas

• Date Initiated by Firm: March 21, 2022
• Create Date: April 15, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0943-2022
• Recall Event ID: 89776
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models; Article no 007384
• Code Information: Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849
• Recalling Firm/ Manufacturer: Breas Medical, Inc.; 16 Esquire Rd; North Billerica MA 01862-2527
• For Additional Information Contact: Chris Southerland; 617-286-5509
• Manufacturer 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
• FDA Determined 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 Christina.Joiner@breas.com 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.