Device recall
Z-2566-2015: FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform…
FDA device recall · Class II · Customed, Inc
Key facts
| Recall number (Z-number) | Z-2566-2015 |
|---|---|
| Recall event | 71721 |
| Product | FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . |
| Product code | NWR |
| Recalling firm | Customed, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2017 |
| 510(k) numbers | K962652 |
| FEI number | 2648727 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 Products in the same recall event
- 1–9 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