Cardinal Health recalls AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511

Recall date

January 11, 2020

Source

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

Recall number

Z-1040-2020

FDA classification

Class II

Brand / firm

Cardinal Health

Sold / distributed

Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.

Why it was recalled

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

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

What was recalled

AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511