Device recall
Z-2959-2020: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-2959-2020 |
|---|---|
| Recall event | 86338 |
| Product | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. |
| Product code | DTQ |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2021 |
| 510(k) numbers | K172220 |
| FEI number | 1828100 |
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