Device recall
Z-0156-2015: Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass…
FDA device recall · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Recall number (Z-number) | Z-0156-2015 |
|---|---|
| Recall event | 58185 |
| Product | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver… |
| Product code | DTR |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2014 |
| 510(k) numbers | K900640 |
| FEI number | 1000149028 |
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