Device recall
Z-0357-06: Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads…
FDA device recall · Class II · Sandhill Scientific, Inc
Key facts
| Recall number (Z-number) | Z-0357-06 |
|---|---|
| Recall event | 34198 |
| Product | Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric… |
| Product code | FAP |
| Recalling firm | Sandhill Scientific, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2006 |
| FEI number | 2023374 |
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