FDA-Drug2019-01-16Class II
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Baxter Healthcare Corporation
Hazard
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Sold states
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Affected count
29,370 bags
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2019Don't want to check this manually?
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