Device recall
Z-0618-2013: Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Recall number (Z-number) | Z-0618-2013 |
|---|---|
| Recall event | 63769 |
| Product | Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R… |
| Product code | DWF |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2013 |
| 510(k) numbers | K012538, K113845, K891687 |
| FEI number | 2182208 |
At a glance
- 1–9 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