FDA Medical Device Recalls (openFDA)
Sandhill Scientific, Inc: ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
- Recall number
- Z-0104-04
- Recalling firm
- Sandhill Scientific, Inc
- Product
- ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
- Status
- Terminated
- Initiated
- 2003-09-24
- Posted
- 2003-11-11
- Terminated
- 2003-11-17
- 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.
- Lot, serial or model codes
- Product Model ZAN S61C01E, Lot Number Z0306005
- 510(k) numbers
- ["K931963"]
- PMA numbers
- not on file
- Product code
- FFT
- Firm FEI
- 2023374
- Firm city
- Highlands Ranch
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28