Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Summary
The FDA issued a Class II for Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models by Breas Medical, Inc.. 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 cau.
Details
Source
Device Recall
External ID
Z-0943-2022
Action Date
2022-04-20
Status
Terminated
Category
device
Product Description
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Lot/Code Info: Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849
Quantity Affected: 707 units
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
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-21
Company
North Billerica, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Breas Medical, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Breas Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Breas Medical, Inc. have FDA actions?
Breas Medical, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0943-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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