Device recall
Z-1083-2010: OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care…
FDA device recall · Class III · OPTI Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-1083-2010 |
|---|---|
| Recall event | 54512 |
| Product | OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. |
| Product code | CGZ |
| Recalling firm | OPTI Medical Systems, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K052027 |
| FEI number | 3004102403 |
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