Device recall
Z-0029-2014: Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes…
FDA device recall · Class II · OPTI Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-0029-2014 |
|---|---|
| Recall event | 66105 |
| Product | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer 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 | JJE |
| Recalling firm | OPTI Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2013 |
| 510(k) numbers | K052027 |
| FEI number | 3004102403 |
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