Device recall
Z-1525-2016: Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306…
FDA device recall · Class II · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-1525-2016 |
|---|---|
| Recall event | 73604 |
| Product | Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a… |
| Product code | EZL |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 11, 2016 |
| FEI number | 2125050 |
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