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D-1276-2014 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-1276-2014 was initiated by Baxter Healthcare Corp. on Feb 11, 2014 and is designated Class I. Reason for recall: Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. The recall status is terminated (terminated Jul 22, 2015). Affected quantity: 27,169 containers.

Recall Details

Product Type: Drugs
Report Date: May 7, 2014
Initiation Date: Feb 11, 2014
Termination Date: Jul 22, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 27,169 containers

Product Description

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11

Reason for Recall

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Distribution Pattern

Nationwide.

Code Information

Lot number: C903799, Exp 05/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1276-2014
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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