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From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Aug 14, 2014 at 7:12 AM
Subject: Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter
To: iammejtm@gmail.com
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From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Aug 14, 2014 at 7:12 AM
Subject: Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter
To: iammejtm@gmail.com
You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).
This information has recently been updated and is now available.
08/14/2014 09:54 AM EDT
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.
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Jeremy Tobias Matthews
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