Device recall
Z-0546-2009: Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0546-2009 |
|---|---|
| Recall event | 49510 |
| Product | Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon. |
| Product code | NKU |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| 510(k) numbers | K053188 |
| FEI number | 3001237663 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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