Class IIOngoing

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose recall

FDA recall D-0587-2024 · initiated Jun 17, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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
Recalling company: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide, Canada
Initiated: Jun 17, 2024
FDA report date: Jul 17, 2024

This recall is linked to a product we cover: Dianeal Low Calcium W/Dextrose 2.5% in Plastic Container →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0587-2024 ↗

← All drug recalls