FDA recall D-1610-2014

Product

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.

Reason for recall

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-08-07

Report date

2014-10-08

Termination date

2017-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1610-2014