Baxter 50 mm 0.2 Micron Filters – Recall Due to Missing Filter Support Membrane
October 11, 2016
FDA is notifying healthcare professionals of a voluntary recall of all unexpired lots of Baxter 50 mm 0.2 micron filters. The filters are being recalled due to possible missing filter support membranes. The product code is H93835 with expiration dating between June 27, 2016, and June 27, 2019. The affected lots were distributed between August 22, 2013, and June 20, 2016. The defective filters were detected prior to patient involvement. No adverse events have been reported.
The Baxter 50 mm 0.2 micron filter is used during the preparation of compounded solutions. Without a filter support membrane, bacteria and particulate matter may pass into the prepared sterile solution. Contaminated solutions administered to patients may result in serious health consequences (eg, sepsis, death). Return unexpired products to Baxter by contacting Baxter Healthcare Center for Service at 1-888-229-0001. Report any adverse events related to the use of these filters to the FDA MedWatch Adverse Event Reporting Program.
- FDA Recall Notice – October 6, 2016
- MedWatch Safety Alert – October 3, 2016
- Baxter Press Release – September 27, 2016
October 11, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.