Z-0104-04

ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system

Name: Z-0104-04 ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
Creator: Sandhill Scientific, Inc
Published: 2003-09-24
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2003-09-24 / Terminated / root cause: labeling and UDI

FDA source

Sandhill Scientific, Inc began a recall of ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system on 2003-09-24. The reason FDA records is "Pouch containing pediatric probes was labeled as containing adult probes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0104-04
Status: Terminated
Initiated: 2003-09-24
Posted: 2003-11-11
Terminated: 2003-11-17
Recalling firm: Diversatek Healthcare Inc
Product: ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
Product code: FFT Electrode, Ph, Stomach
Reason for recall: Pouch containing pediatric probes was labeled as containing adult probes.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The 3 consignees were notified by telephone on 09/24/2003, followed by a letter.
Quantity in commerce: 17 probes
Distribution: CO, MT, TX.
Product codes and lots: Product Model ZAN S61C01E, Lot Number Z0306005

Product code FFT

K931963Class ISandhill Disposable Internal Reference Ph ProbeSandhill Scientific, Inc. / cleared 1994-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)