Baxter Recalls Compounding Filters

Baxter International has begun a recall of all unexpired lots of 50mm 0.2 micron filters (product code H93835) due to the potential for a filter support membrane to be missing and for the 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,” a recall notice says. There have been no adverse events reported to Baxter to date associated with these issues, it says.

The device is a bacteria and particulate filter for aqueous solutions used during 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,” the notice says. “If not further filtered before patient administration, this could lead to adverse health consequences.”