PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: October 8, 2014 Initiated: August 7, 2014 #D-1610-2014

Product Description

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.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
50,530 bags
Distribution
Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corp.. Units affected: 50,530 bags.
Why was this product recalled?
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 8, 2014. Severity: Critical. Recall number: D-1610-2014.