Device recall
Z-1996-2020: Central Venous Catheters are indicated for the assessment of hemodynamic status…
FDA device recall · Class II · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1996-2020 |
|---|---|
| Recall event | 85361 |
| Product | Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4 |
| Product code | DQE |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2022 |
| FEI number | 2025816 |
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