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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Recall Number Z-0197-2014
Classification Class II
Code Info Product Code: 35700BAX, 35700ABB Serial Numbers: All
Product Distributed Qty 273,835 units
Reason For Recall Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

Event Detail

Event Id 66120
Product Type Devices
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA including Puerto Rico and Canada.