Draeger, Inc. recalls Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 S…

The potential for cracks forming in the breathing circuit hose.

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

On March 12, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken When using these breathing circuits: 1. Use holders with a larger contact surface (see Figure 2 above). 2. Perform leak testing after stretching the flexible hose to the required length for the application. Please observe the products Instructions for Use (IFU) According to our records, you have received at least one of the listed breathing circuits. Please inform all potential users in your facility. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification. Please also complete the enclosed Medical Device Recall Return Response Acknowledgment and Receipt Form to confirm to us that you have received this information. Adverse events or quality problems experienced with the use of this product may be reported to FDA s MedWatch Adverse Event Reporting program either online or by phone at 1-800-FDA-1088. We apologize for any inconveniences resulting from this action. If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com. The US Food and Drug Administration has been advised of this action. ****Update 07/08/2025****On June 25, 2025 URGENT MEDICAL DEVICE RECALL - UPDATE letters were sent to consignees to clarify and provide complete UDI information for the device to include both primary and secondary UDI numbers as errors were identified in the initial letter.

• FDA enforcement recordOfficial FDA database entry for Z-1493-2025
• FDA device classification · CAIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5240The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Draeger, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.