Practi-0 recalled over sterility concerns

Recall date

January 6, 2015

Source

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

Official notice title

Wallcur Incorporated recalls Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA,…

Recall number

D-0434-2015

FDA classification

Class I

Brand / firm

Wallcur Incorporated

Sold / distributed

United States including Puerto Rico; and Canada

Why it was recalled

Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.

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

Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.