Recall Z-1497-2025— Draeger, Inc.

Class I · Ongoing

Class I FDA medical device recall by Draeger, Inc., initiated 2025-03-12. FDA's recall record names no specific 510(k) clearance for this event. 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: The potential for cracks forming in the breathing circuit hose..

Recalling firm
Draeger, Inc.
Classification
Class I
Status
Ongoing
Initiated
2025-03-12
Firm location
Telford, PA, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.