FDA recall D-0587-2024

Product

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.

Distribution

US Nationwide, Canada

Key facts

Status

Ongoing

Initiation date

2024-06-17

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0587-2024