FDA-Device2021-12-22Class II
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Cardinal Health
Hazard
Potential for open packaging seals compromising the sterility of the surgical gowns
Sold states
Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Affected count
9,990 units
Manufactured in
1270 Waukegan Rd Bldg C, Waukegan, IL, United States
Products
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0377-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief