Device recall
Z-3073-2017: POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b)…
FDA device recall · Class II · Kentec Medical Inc
Key facts
| Recall number (Z-number) | Z-3073-2017 |
|---|---|
| Recall event | 77729 |
| Product | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE… |
| Product code | FPD |
| Recalling firm | Kentec Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2020 |
| 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