Device recall
Z-2328-2012: CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The…
FDA device recall · Class II · Custom Medical Specialties, Inc.
Key facts
| Recall number (Z-number) | Z-2328-2012 |
|---|---|
| Recall event | 62875 |
| Product | CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep |
| Product code | LRP |
| Recalling firm | Custom Medical Specialties, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2012 |
| FEI number | 3005474845 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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