Device product
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only
Z-1497-2025
Product summary
- Firm
- Draeger, Inc.
- Event
- Event 96342
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 293660 units
- Official record key
device-enforcement:Z-1497-2025
Official wording
Reason: The potential for cracks forming in the breathing circuit hose.
Code information: Model/Catalog Number: MP02744; UDI Number 040486775389675; All lot numbers.
Distribution pattern: 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
Derived failure modes
-
Unknown
The potential for cracks forming in the breathing circuit hose.