FDA recall D-1276-2014

Product

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11

Reason for recall

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2014-02-11

Report date

2014-05-07

Termination date

2015-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1276-2014