Sterile EXACTAMED Oral Dispenser recalled over labeling errors

Recall date

February 6, 2018

Source

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

Official notice title

Baxter Healthcare Corporation recalls Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

Recall number

Z-0806-2018

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.

Why it was recalled

Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).

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

What was recalled

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105