''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
FDA device recall Z-0466-03 · posted 2003-01-23 · Terminated
Recall details
- Recalling firm
- Sandhill Scientific, Inc
- Reason for recall
- Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
- Action taken
- All consignees were notified by letter on 01/08/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFT
- Quantity affected
- 6678 probes
- Distribution
- Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain.
- Date initiated
- 2003-01-08
- Date posted
- 2003-01-23
- Date terminated
- 2003-04-16
- Location
- Highlands Ranch, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963) | Sandhill Scientific, Inc. | 1994-09-28 |