Device recall
Z-0879-2022: DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine…
FDA device recall · Class II · DeRoyal Industries Inc
Key facts
| Recall number (Z-number) | Z-0879-2022 |
|---|---|
| Recall event | 89737 |
| Product | DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection. |
| Product code | LRO |
| Recalling firm | DeRoyal Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2022 |
| 510(k) numbers | K842648 |
| FEI number | 1043214 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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