Device recall
Z-1237-2014: Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product…
FDA device recall · Class II · Convatec Inc.
Key facts
| Recall number (Z-number) | Z-1237-2014 |
|---|---|
| Recall event | 67588 |
| Product | Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the… |
| Product code | KOD |
| Recalling firm | Convatec Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2014 |
| FEI number | 3011987967 |
At a glance
- None 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