Device recall
Z-3072-2017: mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal…
FDA device recall · Class II · Medspira, Llc
Key facts
| Recall number (Z-number) | Z-3072-2017 |
|---|---|
| Recall event | 77706 |
| Product | mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a… |
| Product code | GBT |
| Recalling firm | Medspira, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2021 |
| 510(k) numbers | K120088, K143031 |
| FEI number | 3008414621 |
At a glance
- 1–9 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