Device recall
Z-2081-2012: The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube…
FDA device recall · Class II · Mallinckrodt Inc
Key facts
| Recall number (Z-number) | Z-2081-2012 |
|---|---|
| Recall event | 54724 |
| Product | The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an… |
| Product code | DXT |
| Recalling firm | Mallinckrodt Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2012 |
| 510(k) numbers | K781334 |
| FEI number | 1518293 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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