Device recall
Z-0489-2011: CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology…
FDA device recall · Class II · Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Key facts
| Recall number (Z-number) | Z-0489-2011 |
|---|---|
| Recall event | 56775 |
| Product | CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, CELL-DYN 4000 Vent Needle, List Number: 02H61-01, CELL-DYN 4000 Accessory Kit, List Number… |
| Product code | GKZ |
| Recalling firm | Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2011 |
| FEI number | 2919069 |
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