Device recall
Z-1414-2020: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the…
FDA device recall · Class II · Deroyal Industries, Inc. Lafollette
Key facts
| Recall number (Z-number) | Z-1414-2020 |
|---|---|
| Recall event | 84889 |
| Product | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15 |
| Product code | LRO |
| Recalling firm | Deroyal Industries, Inc. Lafollette |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K842648 |
| FEI number | 3005011024 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1,000+ Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database