Baxter International, Inc., which recently announced a recall for certain lots of its Vascu-Guard Peripheral Vascular Patch device, is pulling another product off the market. This time, the company is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters due to the potential for a missing filter support membrane and the possible presence of particulate matter.
According to a notice posted on the U.S. Food & Drug Administration’s (FDA) website earlier today, Baxter International’s 50mm 0.2 micron filter is a bacteria and particulate filter for aqueous solutions used during the compounding of solutions. If the filter support membrane is missing, bacteria and/or particulate matter present in an unsterile solution could pass through to the compounded prepared solution. This could lead to adverse health consequences if the solution is not further filtered before patient administration.
Baxter distributed the affected Micron filters between August 22, 2013 and June 20, 2016. Those subject to recall bear product code H93835, and expiration dates 6/27/2016 – 6/27/2019.
This is just the most recent product recall involving a medical device marketed by Baxter International. In June, the company recalled certain lots of its Vascu-Guard Peripheral Vascular Patch, after receiving multiple reports of adverse events in patients undergoing carotid endarterectomy (CEA) surgery. The Vascu-Guard Patch recall was designated a Class II recall by the FDA, which indicates that the affected products might cause a temporary health problem, or pose a slight threat of a serious nature or death.
According to a Letter to Healthcare Providers issued on September 1st, adverse events reported in relation to the recalled Vascu-Guard patch involved intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention. The FDA noted that three patient deaths may also be linked to the Vascu-Guard recall.
This past January, the Chicago Tribune reported that Baxter had issued five additional product recalls in 2015.
“For Baxter, recalls are an ongoing issue. The Food and Drug Administration (FDA) website shows numerous recalls each year for the past several years, with some that cost the company millions of dollars,” the Tribune article stated.