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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Recall Number Z-1752-2013
Classification Class II
Code Info ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
Product Distributed Qty 753 units
Reason For Recall Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.

Event Detail

Event Id 65215
Product Type Devices
Status Ongoing
Recalling Firm Baxa Corporation
City Englewood
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.