FDAFDA · Food and drugs·Recall number Z-1416-2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Published March 11, 2020 · Recall initiated: February 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- Distributor
- US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
- Lot
- Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC Thyroid Pack 89-6302.14, Lot numbers: 49310958 exp. 09/01/2023, 49675501 exp. 09/01/203
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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