Device recall
Z-1037-2019: Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-1037-2019 |
|---|---|
| Recall event | 82039 |
| Product | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted… |
| Product code | KOD |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K896729 |
| FEI number | 3011987967 |
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