FDA recall Z-0375-2022

Cardinal Health · Class II · device

Product

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Reason for recall

Potential for open packaging seals compromising the sterility of the surgical gowns

Distribution

Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

Key facts

Status: Ongoing
Initiation date: 2021-11-02
Report date: 2021-12-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0375-2022