Device recall
Z-1328-2009: Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit…
FDA device recall · Class II · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-1328-2009 |
|---|---|
| Recall event | 49127 |
| Product | Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total… |
| Product code | CGL |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2011 |
| 510(k) numbers | K022746 |
| FEI number | 1219029 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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