FDA-Device2022-04-20Class II

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Cardinal Health 200, LLC
Hazard

Product was distributed without being sterilized.

Sold states
Product distributed throughout United States and Guam
Affected count
486,578 pairs
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0902-2022

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