FDA-Device2020-02-26Class II
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Cardinal Health 200, LLC
Hazard
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Sold states
US Nationwide. Chile, Israel, UAE.
Affected count
318,000 units
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2020Don't want to check this manually?
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