Recall: Dianeal Peritoneal Dialysis Solution
On 2014-08-14, the FDA announced that Baxter is conducting a recall on Peritoneal Dialysis Solution due to possible contamination with foreign matter. The recalled products were sold under the brand name(s) Dianeal from May 2014 to July 2014 throughout the regions shown in the map below.
In recent months, there have been 10 drugs recalls due to potential contamination, including cubicin (daptomycin for injection), cubicin (daptomycin for injection) and more. Additionally, there have been 5 drug and medical device recalls due to other health hazards as well as 144 food recalls.
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Detailed Recall Information
Regions Where Sold: Nationwide
Product Description: Peritoneal Dialysis Solution
Brand Name(s): Dianeal
Dates Sold: May 2014 - July 2014
Reason for Recall: Particulate matter
Official Recall Date: 2014-08-13
Note: Although this recall announcement is dated 08/13/2014, it was not published by the FDA until 08/14/2014.
Additional information provided by the FDA.gov:
Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.