Device recall
Z-2761-2015: Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene…
FDA device recall · Class II · Medivators, Inc.
Key facts
| Recall number (Z-number) | Z-2761-2015 |
|---|---|
| Recall event | 72122 |
| Product | Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. |
| Product code | KDI |
| Recalling firm | Medivators, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2015 |
| 510(k) numbers | K983085 |
| FEI number | 2150060 |
At a glance
- 1–9 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