Recall Z-0466-03 ยท FFT Electrode, Ph, Stomach
Sandhill Scientific, Inc
''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
| Date | Jan 23, 2003 (initiated Jan 8, 2003) |
| Status | Terminated |
| Reason | Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication. |
| Root cause | Other |
| Action | All consignees were notified by letter on 01/08/2003. |
| Quantity | 6678 probes |
| Distribution | Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain. |
| 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 |