Recall Z-1496-2025— 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 2 Model/Catalog Number: MP02738 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 Component: Not applicable. 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 2 Model/Catalog Number: MP02738 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 Component: Not applicable

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.