Reported May 23, 2018 · Terminated
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520,…
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?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | Infinity Acute Care System (lACS) Monitoring Solution | |
| 2 | Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818 | |
| 3 | 40490980544544049098054447404909805440940490980097994049098009751 | 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 professionals. 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 Numbers
MS20401MS20724MS22956MS25510MS25520MS25643MS26196MS26372
- MS31818 UDI Information
40490980544544049098054447404909805440940490980097994049098009751
- Catalog Numbers
- Amount recalled
- 25, 629
Where it was sold
- Nationwide
Why it was recalled
Software anomaly resulting in the loss of patient settings and stored patient data.
This product could cause temporary or reversible health problems — stop using it.
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