Device recall
Z-0960-2019: PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during…
FDA device recall · Class II · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-0960-2019 |
|---|---|
| Recall event | 82015 |
| Product | PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices). |
| Product code | MAV |
| Recalling firm | Abbott Vascular |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K962495 |
| FEI number | 2024168 |
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