Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose recall
FDA recall D-0587-2024 · initiated Jun 17, 2024
Baxter Healthcare Corporation recalled Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose in Jun 2024 — an FDA Class II recall (D-0587-2024) because Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
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.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,874 bags
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 Pd-2 W/ Dextrose 3.5% in Plastic Container →
Frequently asked
- Was Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose recalled?
- Baxter Healthcare Corporation recalled Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose in Jun 2024 — an FDA Class II recall (D-0587-2024) because Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose recalled?
- Per the FDA enforcement record, the reason for recall D-0587-2024 was: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- Is a recalled Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose are affected?
- Distributed: US Nationwide, Canada. The recall covers these lots — Lot R24B25FA; Exp. 2/28/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0587-2024.