Device recall
Z-0850-03: Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of…
FDA device recall · Class II · Vygon Corporation
Key facts
| Recall number (Z-number) | Z-0850-03 |
|---|---|
| Recall event | 26213 |
| Product | Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respective accessories are manufactured in the US by Vygon. Sterilization of this catheter tray occurs via… |
| Product code | DQO |
| Recalling firm | Vygon Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 3, 2006 |
| 510(k) numbers | K954112 |
| FEI number | 2245270 |
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