Device recall
Z-0057-2017: The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure…
FDA device recall · Class III · Circulatory Technology Inc
Key facts
| Recall number (Z-number) | Z-0057-2017 |
|---|---|
| Recall event | 74614 |
| Product | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. |
| Product code | DTN |
| Recalling firm | Circulatory Technology Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 14, 2017 |
| 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