ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
FDA device recall Z-0104-04 · posted 2003-11-11 · Terminated
Recall details
- Recalling firm
- Sandhill Scientific, Inc
- Reason for recall
- Pouch containing pediatric probes was labeled as containing adult probes.
- Action taken
- The 3 consignees were notified by telephone on 09/24/2003, followed by a letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFT
- Quantity affected
- 17 probes
- Distribution
- CO, MT, TX.
- Date initiated
- 2003-09-24
- Date posted
- 2003-11-11
- Date terminated
- 2003-11-17
- 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 |