Device recall
Z-0300-2010: 24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON FUNNEL TIP…
FDA device recall · Class II · Spire Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0300-2010 |
|---|---|
| Recall event | 53605 |
| Product | 24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Latex free. |
| Product code | MSD |
| Recalling firm | Spire Biomedical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2010 |
| 510(k) numbers | K032061, K040509, K042858, K060155, K063431, K063441 |
| FEI number | 1000159376 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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