Device recall
Z-0068-04: Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing…
FDA device recall · Class II · Wilson-Cook Medical Inc
Key facts
| Recall number (Z-number) | Z-0068-04 |
|---|---|
| Recall event | 27445 |
| Product | Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105. |
| Product code | GCA |
| Recalling firm | Wilson-Cook Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2003 |
| 510(k) numbers | K953951 |
| FEI number | 1037905 |
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