PlainRecalls
FDA Drug Moderate Class II Completed

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.

Reported: May 3, 2023 Initiated: March 15, 2023 #D-0543-2023

Product Description

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.

Reason for Recall

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

Details

Units Affected
9,788 bags
Distribution
Nationwide in the USA
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.. Recalled by Baxter Healthcare Corporation. Units affected: 9,788 bags.
Why was this product recalled?
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0543-2023.