Device recall
Z-2535-2020: Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use…
FDA device recall · Class II · LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Key facts
| Recall number (Z-number) | Z-2535-2020 |
|---|---|
| Recall event | 85655 |
| Product | Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes. |
| Product code | FEZ |
| Recalling firm | LABORIE MEDICAL TECHNOLOGIES, CANADA ULC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2021 |
| FEI number | 3001438491 |
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