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
Reported: April 9, 2025 Initiated: March 12, 2025 #Z-1493-2025
Product Description
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
Reason for Recall
The potential for cracks forming in the breathing circuit hose.
Details
- Recalling Firm
- Draeger, Inc.
- Units Affected
- 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
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Draeger, Inc.. Units affected: 65150 units.
Why was this product recalled? ▼
The potential for cracks forming in the breathing circuit hose.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Critical. Recall number: Z-1493-2025.
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