FDA recall D-1326-2015

Product

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

Reason for recall

Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.

Distribution

TX and TN

Key facts

Status

Terminated

Initiation date

2015-07-02

Report date

2015-08-19

Termination date

2016-05-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1326-2015