Device recall
Z-0893-04: A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx…
FDA device recall · Class II · Ventlab Corporation
Key facts
| Recall number (Z-number) | Z-0893-04 |
|---|---|
| Recall event | 28689 |
| Product | A.C.E. STAT-Check CO Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028 |
| 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