FDA Drug recall D-1276-2014

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerf…

• FDA Drug
• Class I
• terminated
• Published 2014-05-07

On 2014-05-07 the FDA classified a Class I recall of Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerf… by Baxter Healthcare, citing non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Read the official FDA Drug notice

Product

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

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

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-1276-2014%22

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