Device recall
Z-2788-2015: Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE…
FDA device recall · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Recall number (Z-number) | Z-2788-2015 |
|---|---|
| Recall event | 72010 |
| Product | Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by… |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2016 |
| FEI number | 1000149028 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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