Baxter International Inc. March 5 said it has initiated a voluntary recall in the U.S. of a single lot of Dianeal PD-2 peritoneal dialysis solution with 1.5 percent dextrose 6000 mL (Ambu-Flex II).
The recall is a result of complaints of particulate matter, identified as mold, resulting from a leak in the container, the company said. Dianeal is a peritoneal dialysis (PD) solution for use in chronic renal failure patients being maintained on PD therapy.
Product affected by this recall was packaged in flexible plastic containers and distributed to dialysis centers, facilities, distributors and patients in the U.S., Baxter said. ...
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