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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 Recall
ExactaMix 1200 and 2400 Compounders
see related information
Date Posted July 18, 2013
Recall Status1 Open
Recall Number Z-1752-2013
Recall Event ID 65215
Premarket Notification
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
14445 Grasslands Dr
Englewood, Colorado 80112-7062
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = BAXA CORP.
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