Device recall
Z-0004-2013: Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is…
FDA device recall · Class II · Cure Medical LLC
Key facts
| Recall number (Z-number) | Z-0004-2013 |
|---|---|
| Recall event | 63241 |
| Product | Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an… |
| Product code | EZD |
| Recalling firm | Cure Medical LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2013 |
| 510(k) numbers | K072539 |
| FEI number | 3005471919 |
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