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U.S. Department of Health and Human Services

Class 2 Device Recall EXACTAMIX Compounder

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 Class 2 Recall
EXACTAMIX Compounder
see related information
Date Posted July 01, 2014
Recall Status1 Open
Recall Number Z-1963-2014
Recall Event ID 68506
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
Code Information model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield, Illinois 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Baxter is issuing a field correction for the EXACTAMIX Compounder due to the potential that If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.
FDA Determined
Cause 2
DESIGN: Software Design
Action An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.
Quantity in Commerce 1758
Distribution US Nationwide
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.
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