Device recall
Z-0714-2013: Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE…
FDA device recall · Class II · Medisystems a NX Stage Company
Key facts
| Recall number (Z-number) | Z-0714-2013 |
|---|---|
| Recall event | 63959 |
| Product | Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion. |
| Product code | FIE |
| Recalling firm | Medisystems a NX Stage Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 10, 2013 |
| 510(k) numbers | K990803 |
| FEI number | 3003464075 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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