Home / Recalls / Medical Devices
Cardinal Health recalls ROYALSILK LARGE, Gown. Item Code 9518
Recalled February 12, 2020 · FDA recall Z-1022-2020 · Cardinal Health
Hazard
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. · FDA Class II
Units
7,659,634 total units
Sold at
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.
Description
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Product
ROYALSILK LARGE, Gown. Item Code 9518
Manufacturer(s)
Cardinal Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →