Device recall
Z-0974-2014: 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical…
FDA device recall · Class II · Custom Medical Specialties, Inc.
Key facts
| Recall number (Z-number) | Z-0974-2014 |
|---|---|
| Recall event | 65753 |
| Product | 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover |
| Product code | KKX |
| Recalling firm | Custom Medical Specialties, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2014 |
| 510(k) numbers | K882724 |
| FEI number | 3005474845 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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