FDA Drug recall D-831-2013

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation,…

• FDA Drug
• Class II
• terminated
• Published 2013-08-07

On 2013-08-07 the FDA classified a Class II recall of DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation,… by Baxter Healthcare, citing defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Read the official FDA Drug notice

Product

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07

Reason

Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-831-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.