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D-831-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-831-2013 was initiated by Baxter Healthcare Corp. on Jul 24, 2013 and is designated Class II. Reason for recall: Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed. The recall status is terminated (terminated Jun 24, 2014). Affected quantity: 39,486 containers.

Recall Details

Product Type: Drugs
Report Date: Aug 7, 2013
Initiation Date: Jul 24, 2013
Termination Date: Jun 24, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 39,486 containers

Product Description

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 for Recall

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

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Product Code: L5B4826, Lot #: C886820, Exp 11/14

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-831-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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