Device recall
Z-1171-2018: **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary…
FDA device recall · Class II · Circulatory Technology Inc
Key facts
| Recall number (Z-number) | Z-1171-2018 |
|---|---|
| Recall event | 79196 |
| Product | **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers) |
| Product code | DTN |
| Recalling firm | Circulatory Technology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2020 |
| 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