Reported Apr 25, 2018 · Terminated
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956,…
Draegar Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draegar Medical Systems, Inc. · 6 Tech Dr · Andover, MA · 01810-2434
Is this the product you have?
- Infinity Acute Care System (IACS) Monitoring Solution
- Catalog Numbers
MS18841MS20401MS20407MS20724MS22956MS25510MS25520MS25643MS26196MS26372MS31818
- UDI Information4049098054454, 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
- Lot codes and dates
- Catalog Number(s)
MS18841MS20401MS20407MS20724MS22956MS25510MS25520MS25643MS26196MS26372MS31818
- UDI Information
40490980544544049098054447404909805440940490980097994049098009751
- Catalog Number(s)
- Amount recalled
- 28317 total products
Where it was sold
- Nationwide
Why it was recalled
The invasive pressure visual and audible alarms may not activate.
This product could cause temporary or reversible health problems — stop using it.
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