Vivo 45 LS recall
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or…
Why was Vivo 45 LS recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
- Product
- Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or…
- Recalling firm
- Breas Medical, Inc.
- Quantity
- 8298
- Distribution
- US Nationwide.
- Recall date
- September 11, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)