Device recall
Z-0975-2009: Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A…
FDA device recall · Class II · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-0975-2009 |
|---|---|
| Recall event | 50161 |
| Product | Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacturer: Medtronic Inc., Minneapolis, MN 55432-5604. Surgical Membrane Oxygenators are intended to be used in… |
| Product code | DTZ |
| Recalling firm | Medtronic Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2011 |
| FEI number | 3001504994 |
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