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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMix 1200 and 2400 Compounders

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  Class 2 Device Recall ExactaMix 1200 and 2400 Compounders see related information
Date Initiated by Firm June 04, 2013
Date Posted July 18, 2013
Recall Status1 Terminated 3 on October 16, 2015
Recall Number Z-1752-2013
Recall Event ID 65215
510(K)Number K002705  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product ExactaMix 1200 and 2400 Compounders.

Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
Code Information ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
Recalling Firm/
Manufacturer		 Baxa Corporation
9540 Maroon Cir Unit 400
Englewood CO 80112-5731
For Additional Information Contact Customer Service
303-690-4204
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 6/04/13, customers were notified by 1st class mailing with mitigating instructions including reminding customers that the battery failure results in a failure of the ExactaMix system to alert the user to replace the disposable set after 24 hours of use. Users should not rely on the alert to trigger the daily replacement of disposable sets. Users should also confirm the correct time and date at the setup of each use. If the compounder displays an incorrect time and date, customers are to contact Baxter Technical Support.
Quantity in Commerce 753 units
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = BAXA CORP.
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