Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infinity Acute Care System (IACS) Monitoring Solution Recalled by Draegar Medical Systems, Inc. Due to The invasive pressure visual and audible alarms may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Draegar Medical Systems, Inc. directly.
Affected Products
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
Quantity: 28317 total products
Why Was This Recalled?
The invasive pressure visual and audible alarms may not activate.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Draegar Medical Systems, Inc.
Draegar Medical Systems, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report