Device recall
Z-2277-2012: 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit…
FDA device recall · Class III · Bard Access Systems
Key facts
| Recall number (Z-number) | Z-2277-2012 |
|---|---|
| Recall event | 62780 |
| Product | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis… |
| Product code | MSD |
| Recalling firm | Bard Access Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 7, 2013 |
| FEI number | 3006260740 |
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