Device recall
Z-0305-04: Pentalumen TD Thermodilution Catheter, Sterile
FDA device recall · Class III · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-0305-04 |
|---|---|
| Recall event | 27788 |
| Product | Pentalumen TD Thermodilution Catheter, Sterile |
| Product code | DYG |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 14, 2004 |
| 510(k) numbers | K812800, K832957 |
| FEI number | 1415939 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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