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

FDA recall notice · announced May 7, 2014 · Baxter Healthcare

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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 for recall

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

Notes

Distribution: Nationwide.
Lot/code information: Lot number: C903799, Exp 05/15
Quantity: 27,169 containers
Status: Terminated
Products in this recall event:
- 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 (D-1276-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.