Device recall
Z-2710-2011: The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO…
FDA device recall · Class II · Urologix, Inc.
Key facts
| Recall number (Z-number) | Z-2710-2011 |
|---|---|
| Recall event | 58695 |
| Product | The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North… |
| Product code | MEQ |
| Recalling firm | Urologix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2012 |
| PMA numbers | P970008 |
| FEI number | 3000718675 |
At a glance
- None Linked 510(k)s
- 1–9 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