FDA recall D-0957-2016

Product

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02

Reason for recall

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-15

Report date

2016-06-15

Termination date

2022-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0957-2016