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, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL…

Recall number

D-0957-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide in USA

Why it was recalled

Lack of Assurance of Sterility: Customer complaints for leaking bags.

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, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.