Drug recall
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack…
FDA recall event 84889 · Class II · Deroyal Industries, Inc. Lafollette
Key facts
| Event ID | 84889 |
|---|---|
| Recall numbers | Z-1410-2020, Z-1411-2020, Z-1412-2020, Z-1413-2020, Z-1414-2020, Z-1415-2020, Z-1416-2020, Z-1417-2020, Z-1418-2020, Z-1419-2020 |
| Recalling firm | Deroyal Industries, Inc. Lafollette |
| Product type | Devices |
| Products | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16, DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13, DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13, DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14, DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17 and 5 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Initiation date | Feb 4, 2020 |
| Report date | Mar 11, 2020 |
| Termination date | Apr 1, 2021 |
| City | La Follette |
| State | TN |
| Country | United States |
| FEI number | 3005011024 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: