FDA-Device2020-03-11Class II
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Deroyal Industries, Inc. Lafollette
Hazard
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Sold states
US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
Affected count
2100 units
Manufactured in
1501 E Central Ave, N/A, La Follette, TN, United States
Products
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2020Don't want to check this manually?
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