FDA recall D-0543-2023

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Completed

Initiation date

2023-03-15

Report date

2023-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2023