Medical Device Safety and Recalls: Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination

Baxter Corp. is recalling the 50 mm 0.2 Micron Filter after receiving reports about the presence of particulate matter and the potential absence of filter membrane layers in the filter set. The absence of a filter membrane layer and/or the presence of particulate matter in the set may contaminate a solution. This could result in bloodstream infections that may cause fever, septic shock, multiple organ dysfunction, and other serious adverse health consequences including death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm524230.htm

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