FDA recall Z-1497-2025

Draeger, Inc. · Class I · 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

Reason for recall

The potential for cracks forming in the breathing circuit hose.

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

Key facts

Status
Ongoing
Initiation date
2025-03-12
Report date
2025-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2025