Device recall
Z-1458-2015: Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs…
FDA device recall · Class II · Del Mar Reynolds Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-1458-2015 |
|---|---|
| Recall event | 70754 |
| Product | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia. |
| Product code | CBK |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2015 |
| 510(k) numbers | K112729 |
| FEI number | 3002807992 |
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