Breas Medical, Inc. Recall 89776
Description: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Breas Medical, Inc. Recall 89776 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0943-2022 |
Event ID | 89776 |
Event Description | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384 |
Product Type | Devices |
Distribution | US Nationwide |
Quantity | 707 units |
Recall 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 |
Device Classification | 20220420 |
Device Code Info | Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849 |
Center Classification Date | 20220414 |
Recall Initiation Date | 20220321 |
Recalling Firm | Breas Medical, Inc. |
Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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