Voluntary Recall of all Unexpired Lots of Baxter International's 50mm 0.2 Micron Filters

PUBLISHED: Oct 3, 2016
Source: Food and Drug Administration

Baxter International Inc. of Deerfield, Illinois, has initiated a voluntary recall of all unexpired lots of 50mm 0.2 micron filters (product code H93835, expiration date 6/27/2016 – 6/27/2019) 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. There have been no adverse events reported to Baxter to date associated with these issues.

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.

The lots being recalled were distributed to customers and distributors globally between August 22, 2013 and June 20, 2016. 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 1-888-229-0001, Monday through Friday, between the hours of 7 a.m. and 6 p.m., Central Time. Although the product has been discontinued for reasons unrelated to this recall, Baxter will work with customers to direct them toward suitable alternative products, if necessary.

Customers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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