August 15th, 2014
Voluntary Recall: Peritoneal Dialysis Solution
Baxter announced today that it is in the process of recalling two lots of peritoneal dialysis solution.
The drug, DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000 mL (Ambu-Flex II), is used for chronic renal failure patients.
The voluntary recall is due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter. The company has received no reports of adverse events, but administration of the product with the particulate matter could lead to local inflammation, adhesion formation, and could potentially lead to a fatal infection.
The following lots, distributed between May 30, 2014 and July 9, 2014, are being recalled:
Product Code NDC Number Lot # Expiration Date
L5B5202 0941-0457-05 C940700 May 31, 2016
L5B5202 0941-0457-05 C940841 May 31, 2016
Reference:
1. Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter [press release]. 2014 Aug 13.
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