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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64447
Product Type Devices
Status Ongoing
Recalling Firm Draeger Medical, Inc.
City Telford
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distributed in the states of CA, IL, and MA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Class II 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. 260 Z-0939-2013
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