Cardinal Health 200, LLC recalls Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1…

Recall date

January 31, 2020

Source

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

Recall number

Z-1235-2020

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

US Nationwide.

Why it was recalled

The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.

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

What was recalled

Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.