Z-0466-03

''ComforTEC II Single Use pH Probe * Latex Free * Do Not Re-use''. Packaged individually

Name: Z-0466-03 ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually
Creator: Sandhill Scientific, Inc
Published: 2003-01-08
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2003-01-08 / Terminated

FDA source

Sandhill Scientific, Inc began a recall of ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually on 2003-01-08. The reason FDA records is "Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0466-03
Status: Terminated
Initiated: 2003-01-08
Posted: 2003-01-23
Terminated: 2003-04-16
Recalling firm: Diversatek Healthcare Inc
Product: ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
Product code: FFT Electrode, Ph, Stomach
Reason for recall: Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
FDA root cause: Other
Action: All consignees were notified by letter on 01/08/2003.
Quantity in commerce: 6678 probes
Distribution: Nationwide. Foreign distribution to Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands, Spain.
Product codes and lots: All product models: C2NS, C2NS-P, C2NS-A, C2N5, C2N10, C2N15, C2N10-V, C2IS, C2I5, C2I10, C2I15, C2I10-V. All lot numbers: U02314 through U021216N-15G.

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)