Device recall
Z-0590-2012: DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from…
FDA device recall · Class II · Angiodynamics, Inc.
Key facts
| Recall number (Z-number) | Z-0590-2012 |
|---|---|
| Recall event | 59833 |
| Product | DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in… |
| Product code | MSD |
| Recalling firm | Angiodynamics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2016 |
| 510(k) numbers | K080400, K101843 |
| FEI number | 1319211 |
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