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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

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

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.
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