Device recall
Z-0291-2010: 36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr Polyurethane twin…
FDA device recall · Class II · Spire Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-0291-2010 |
|---|---|
| Recall event | 53605 |
| Product | 36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit 28cm Decathlon Std Kit. |
| 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