Device recall
Z-0441-2009: 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11…
FDA device recall · Class II · Medtronic, Inc.
Key facts
| Recall number (Z-number) | Z-0441-2009 |
|---|---|
| Recall event | 50078 |
| Product | 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial… |
| Product code | DYB |
| Recalling firm | Medtronic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2011 |
| 510(k) numbers | K955785 |
| FEI number | 1220452 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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