FDA-Drug2014-10-08Class I

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.

Baxter Healthcare Corp.
Hazard

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Sold states
Nationwide
Affected count
50,530 bags
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1610-2014

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