FDAClass IApril 9, 2025

Brand Name: VentStar Product Name: VentStar Flex 220 recall

Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing…

Why was Brand Name: VentStar Product Name: VentStar Flex 220 recalled?

The potential for cracks forming in the breathing circuit hose.

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/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers

Product
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing…
Recalling firm
Draeger, Inc.
Quantity
65150 units
Distribution
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom
Recall date
April 9, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls