Reported Mar 20, 2013 · Terminated
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo)…
Draeger Medical, 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: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
- Lot codes and dates
- Catalog Number MS20783 (Infinity MCable-Dual Hemo)
- Amount recalled
- 260
Where it was sold
Why it was recalled
The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
This product could cause temporary or reversible health problems — stop using it.
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