FDA recall D-831-2013

Product

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07

Reason for recall

Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-07-24

Report date

2013-08-07

Termination date

2014-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-831-2013