Device recall
Z-1862-2021: The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO)…
FDA device recall · Class II · Circulatory Technology Inc.
Key facts
| Recall number (Z-number) | Z-1862-2021 |
|---|---|
| Recall event | 88000 |
| Product | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 |
| Product code | DTN |
| Recalling firm | Circulatory Technology Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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