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U.S. Department of Health and Human Services

Class 3 Device Recall Disposable Internal Reference Impedance Probe

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  Class 3 Device Recall Disposable Internal Reference Impedance Probe see related information
Date Initiated by Firm September 24, 2003
Date Posted November 11, 2003
Recall Status1 Terminated 3 on November 17, 2003
Recall Number Z-0104-04
Recall Event ID 27519
510(K)Number K931963  
Product Classification Electrode, Ph, Stomach - Product Code FFT
Product ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
Code Information Product Model ZAN S61C01E, Lot Number Z0306005
Recalling Firm/
Sandhill Scientific, Inc
9150 Commerce Center Cir Ste 500
Highlands Ranch CO 80129-1563
For Additional Information Contact
Manufacturer Reason
for Recall
Pouch containing pediatric probes was labeled as containing adult probes.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FFT and Original Applicant = SANDHILL SCIENTIFIC, INC.