October 4, 2016

FDA: Recall of Baxter 50 mm 0.2 micron filters

By: Judy Mathias
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Editor's Note

The Food and Drug Administration on October 3 announced the recall by Baxter International (Deerfield, Illinois) of its 50 mm 0.2 micron filters because of the potential for a missing filter support membrane and for potential presence of particulate matter.

The filter is a bacteria and particulate filter used during the compounding of solutions. In the absence of the filter support membrane, bacteria and particulate matter present in an unsterile solution could pass through to the compounded prepared solution.

If no further filtering is done before patient administration, this could lead to adverse patient consequences.

FDA3Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.

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