Device recall
Z-0904-2008: Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is…
FDA device recall · Class II · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-0904-2008 |
|---|---|
| Recall event | 46151 |
| Product | Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404 |
| Product code | DYB |
| Recalling firm | Cook, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2008 |
| FEI number | 1820334 |
At a glance
- None 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