Device recall
Z-0035-2007: SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
FDA device recall · Class II · Haemonetics Corporation
Key facts
| Recall number (Z-number) | Z-0035-2007 |
|---|---|
| Recall event | 36005 |
| Product | SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US |
| Product code | BTA |
| Recalling firm | Haemonetics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2006 |
| 510(k) numbers | K052626 |
| FEI number | 1219343 |
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