Recall Z-0943-2022 ยท CBK Ventilator, Continuous, Facility Use
Breas Medical, Inc.
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
| Date | Mar 21, 2022 |
| Status | Terminated |
| Reason | 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 | 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 possessi |
| Quantity | 707 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.