PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 7, 2014 Initiated: February 11, 2014 #D-1276-2014

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.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
27,169 containers
Distribution
Nationwide.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Baxter Healthcare Corp.. Units affected: 27,169 containers.
Why was this product recalled?
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 7, 2014. Severity: Critical. Recall number: D-1276-2014.