Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.

FDA recall notice · announced October 8, 2014 · Baxter Healthcare

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

The product

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.

Reason for recall

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Notes

Distribution: Nationwide
Lot/code information: Lot #: C940700, C940841, Exp 05/16
Quantity: 50,530 bags
Status: Terminated
Products in this recall event:
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, (D-1610-2014)

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