Recall Z-0104-04 ยท FFT Electrode, Ph, Stomach
Sandhill Scientific, Inc
ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
| Date | Nov 11, 2003 (initiated Sep 24, 2003) |
| Status | Terminated |
| Reason | Pouch containing pediatric probes was labeled as containing adult probes. |
| Root cause | Other |
| Action | The 3 consignees were notified by telephone on 09/24/2003, followed by a letter. |
| Quantity | 17 probes |
| Distribution | CO, MT, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE Sandhill Scientific, Inc., Sep 28, 1994 |