Device recall
Z-0789-2020: Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF…
FDA device recall · Class II · Abbott Medical
Key facts
| Recall number (Z-number) | Z-0789-2020 |
|---|---|
| Recall event | 84459 |
| Product | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is… |
| Product code | DYB |
| Recalling firm | Abbott Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2020 |
| 510(k) numbers | K914090 |
| FEI number | 3005334138 |
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