FDA Drug recall D-0587-2024

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag,…

• FDA Drug
• Class II
• ongoing
• Published 2024-07-17

On 2024-07-17 the FDA classified a Class II recall of Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag,… by Baxter Healthcare, citing lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Read the official FDA Drug notice

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

Reason

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0587-2024%22

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