Device recall
Z-2412-2011: DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO…
FDA device recall · Class II · R4 Vascular Inc
Key facts
| Recall number (Z-number) | Z-2412-2011 |
|---|---|
| Recall event | 58735 |
| Product | DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369. Description Model # Duraspan Kit - 24cm 62152420 Duraspan Kit - 28cm 62152820 Duraspan Kit - 32cm 62153220 Duraspan Exchange Kit… |
| Product code | MSD |
| Recalling firm | R4 Vascular Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2012 |
| 510(k) numbers | K091506, K100169 |
| FEI number | 3006242715 |
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