PlainRecalls
FDA Drug Moderate Class II Ongoing

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

Reported: July 17, 2024 Initiated: June 17, 2024 #D-0587-2024

Product Description

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

Reason for Recall

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Details

Units Affected
6,874 bags
Distribution
US Nationwide, Canada
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01. Recalled by Baxter Healthcare Corporation. Units affected: 6,874 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 17, 2024. Severity: Moderate. Recall number: D-0587-2024.