PlainRecalls
FDA Drug Moderate Class II Terminated

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

Reported: September 6, 2023 Initiated: August 11, 2023 #D-1141-2023

Product Description

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

Reason for Recall

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

Details

Units Affected
22,112 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, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07. Recalled by Baxter Healthcare Corporation. Units affected: 22,112 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 September 6, 2023. Severity: Moderate. Recall number: D-1141-2023.