FDA recall D-1141-2023

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-08-11

Report date

2023-09-06

Termination date

2024-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1141-2023