FDA recall Z-1012-2020

Product

AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC

Reason for recall

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-01-11

Report date

2020-02-12

Termination date

2023-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2020