FDA recall D-1591-2014

Product

0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Reason for recall

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Distribution

Nationwide, Puerto Rico, Singapore, and Hong Kong

Key facts

Status

Terminated

Initiation date

2014-07-11

Report date

2014-09-24

Termination date

2016-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1591-2014