Device recall
Z-2519-2020: Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile…
FDA device recall · Class II · Kentec Medical, Inc
Key facts
| Recall number (Z-number) | Z-2519-2020 |
|---|---|
| Recall event | 85430 |
| Product | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port). |
| Product code | FPD |
| Recalling firm | Kentec Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2022 |
| 510(k) numbers | K100526 |
| FEI number | 2080225 |
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