FDA recall Z-0368-2022

Product

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

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-0368-2022