Baxter Initiates Recall of Micron Filters Due to Missing Membrane, Particulate Matter
an unsterile solution could pass through to the compounded prepared solution
Baxter International is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters due to the potential for a missing filter support membrane and for potential presence of particulate matter.
These issues are associated with a component manufactured by an external supplier, and were identified prior to patient involvement as a result of complaints from customers at compounding facilities.
The recalled filters have a product code of H93835 and an expiration date of June 27, 2016 through June 27, 2019.
The 50mm 0.2 micron filter is a bacteria and particulate filter for aqueous solutions used during the compounding of solutions.
In the absence of the filter support membrane, bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution.
If not further filtered before patient administration, this could lead to adverse health consequences.
There have been no adverse events reported to Baxter to date associated with these issues.
Baxter is directing customers not to use the product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at (888) 229-0001.