Device recall
Z-1527-2012: Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and…
FDA device recall · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Recall number (Z-number) | Z-1527-2012 |
|---|---|
| Recall event | 61644 |
| Product | Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399 |
| Product code | DTZ |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2013 |
| 510(k) numbers | K071494 |
| FEI number | 1000149028 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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