FDAFDA · Food and drugs·Recall number Z-0939-2013
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Published March 20, 2013 · Recall initiated: December 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger Medical, Inc.
- Distributor
- Distributed in the states of CA, IL, and MA.
- Lot
- Catalog Number MS20783 (Infinity MCable-Dual Hemo)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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