Device recall
Z-2249-2018: Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c)…
FDA device recall · Class II · Vascular Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-2249-2018 |
|---|---|
| Recall event | 80135 |
| Product | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures. |
| Product code | KGZ |
| Recalling firm | Vascular Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| FEI number | 3002827704 |
At a glance
- None 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