Device recall
Z-0895-04: STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure…
FDA device recall · Class II · Ventlab Corporation
Key facts
| Recall number (Z-number) | Z-0895-04 |
|---|---|
| Recall event | 28689 |
| Product | STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336)… |
| Product code | BTM |
| Recalling firm | Ventlab Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 7, 2004 |
| 510(k) numbers | K982215 |
| FEI number | 1314417 |
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