Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati
Summary
The FDA issued a Class I for Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or i by Breas Medical, Inc.. Reason: There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific c.
Details
Source
Device Recall
External ID
Z-2690-2024
Action Date
2024-09-11
Status
Ongoing
Category
device
Product Description
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
Lot/Code Info: Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
Quantity Affected: 8298
Reason for Recall
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-25
Company
North Billerica, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 363 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-2690-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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