Device recall
Z-2832-2016: The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM…
FDA device recall · Class II · Circulatory Technology Inc
Key facts
| Recall number (Z-number) | Z-2832-2016 |
|---|---|
| Recall event | 74991 |
| Product | The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control… |
| Product code | DTN |
| Recalling firm | Circulatory Technology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2018 |
| 510(k) numbers | K981284 |
| FEI number | 1000522036 |
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