Baxter Healthcare product recalled over sterility concerns

Recall date

July 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 600…

Recall number

D-0973-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide, Puerto Rico and Saudi Arabia

Why it was recalled

Lack of Assurance of Sterility: Bags have the potential to leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38