Baxter Healthcare Corp. recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx
Recalled October 8, 2014 · FDA recall D-1610-2014 · Baxter Healthcare
Hazard
Presence of Particulate Matter: particulate matter was found during the manufacturing process. · FDA Class I
Units
50,530 bags
Sold at
Nationwide
Description
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →