FDAFDA · Food and drugs·Recall number Z-1493-2025
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
Published April 9, 2025 · Recall initiated: March 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The potential for cracks forming in the breathing circuit hose.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger, Inc.
- Distributor
- 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
- Lot
- Model/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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