Device recall
Z-0035-04: Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag…
FDA device recall · Class II · VIASYS Med Systems
Key facts
| Recall number (Z-number) | Z-0035-04 |
|---|---|
| Recall event | 27242 |
| Product | Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder… |
| Product code | CAI |
| Recalling firm | VIASYS Med Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2004 |
| 510(k) numbers | K930252 |
| FEI number | 3011270181 |
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