Baxter Healthcare Corp recalls 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield,…

Recall date

December 4, 2014

Source

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

Recall number

D-481-2015

FDA classification

Class I

Brand / firm

Baxter Healthcare Corp

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.