Deroyal Industries, Inc. Lafollette recalls DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
- Recall date
- February 4, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1419-2020
- FDA classification
- Class II
- Brand / firm
- Deroyal Industries, Inc. Lafollette
- Sold / distributed
- US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
Why it was recalled
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
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