Device recall
Z-0304-2010: 28CM DECATHLON MINI KIT Model: DM23SH28 DECATHLON MINI KIT 15.5 Fr polyurethane…
FDA device recall · Class II · Spire Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0304-2010 |
|---|---|
| Recall event | 53605 |
| Product | 28CM DECATHLON MINI KIT Model: DM23SH28 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling… |
| 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