Baxter Healthcare product recalled over sterility concerns

Recall date

January 21, 2016

Source

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

Official notice title

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…

Recall number

D-0861-2016

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

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, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.