Device recall
Z-1120-2012: Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve…
FDA device recall · Class II · Mallinckrodt Inc
Key facts
| Recall number (Z-number) | Z-1120-2012 |
|---|---|
| Recall event | 61187 |
| Product | Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 100 pouches per case. Sterile, The purpose of this product is the injection of contrast media by means of power injector… |
| Product code | DXT |
| Recalling firm | Mallinckrodt Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 24, 2013 |
| 510(k) numbers | K984088 |
| 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