Device recall
Z-2440-2012: BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in…
FDA device recall · Class II · OPTI Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2440-2012 |
|---|---|
| Recall event | 62606 |
| Product | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or… |
| Product code | CHL |
| Recalling firm | OPTI Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2013 |
| 510(k) numbers | K093280 |
| 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