PlainRecalls
FDA Drug Moderate Class II Terminated

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

Reported: January 16, 2019 Initiated: January 2, 2019 #D-0351-2019

Product Description

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

Reason for Recall

Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

Details

Units Affected
29,370 bags
Distribution
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.. Recalled by Baxter Healthcare Corporation. Units affected: 29,370 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0351-2019.