Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity M...
FDA Recall #Z-0939-2013 — Class II — December 13, 2012
Product Description
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Reason for Recall
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.
Recalling Firm
Draeger Medical, Inc. — Telford, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
260
Distribution
Distributed in the states of CA, IL, and MA.
Code Information
Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated