Device recall
Z-0309-2010: 24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD…
FDA device recall · Class II · Spire Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0309-2010 |
|---|---|
| Recall event | 53605 |
| Product | 24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe… |
| 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