Device recall
Z-1036-2019: Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-1036-2019 |
|---|---|
| Recall event | 82039 |
| Product | Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum… |
| Product code | FPD |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K896734 |
| FEI number | 3011987967 |
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