FDA-Drug2024-07-17Class II

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

Baxter Healthcare Corporation
Hazard

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Sold states
US Nationwide, Canada
Affected count
6,874 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, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0587-2024

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