FDA-Drug2013-08-07Class II

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07

Baxter Healthcare Corp.
Hazard

Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Sold states
Nationwide and Puerto Rico
Affected count
39,486 containers
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-831-2013

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