Device recall
Z-2350-2012: CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep…
FDA device recall · Class I · Custom Medical Specialties, Inc.
Key facts
| Recall number (Z-number) | Z-2350-2012 |
|---|---|
| Recall event | 62132 |
| Product | CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep |
| Product code | LRO |
| Recalling firm | Custom Medical Specialties, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 29, 2013 |
| FEI number | 3005474845 |
At a glance
- None 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