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Recall Observatory FDA recall evidence

Device product

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 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-1499-2025

March 12, 2025

Class I

Product summary

Firm
Draeger, Inc.
Event
Event 96342
Status
Ongoing
Classification
Class I
Quantity
13620 units
Official record key
device-enforcement:Z-1499-2025

Official wording

Reason: The potential for cracks forming in the breathing circuit hose.

Code information: Model/Catalog Number: MP17103; UDI Number 04048675695660; 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

    reason.no_named_rule · v1.0.0

    The potential for cracks forming in the breathing circuit hose.