Device recall
Z-2409-2011: SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO…
FDA device recall · Class II · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-2409-2011 |
|---|---|
| Recall event | 58681 |
| Product | SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1400 SureCath Set,acc CH8 Male,bulk 28023S 1400 Surecath Set,acc CH10 Male,bul 28024S 1400 Surecath Set,acc CH12 Male,bul 280320 1400 SureCath Set,acc CH14 Male 28032S 1400 Surecath… |
| Product code | EZD |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2012 |
| FEI number | 2125050 |
At a glance
- None 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