Class 3 Device Recall Disposable Internal Reference Impedance Probe

• Date Initiated by Firm: September 24, 2003
• Date Posted: November 11, 2003
• Recall Status: Terminated 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/ Manufacturer: Sandhill Scientific, Inc; 9150 Commerce Center Cir Ste 500; Highlands Ranch CO 80129-1563
• For Additional Information Contact: 303-470-7020
• Manufacturer Reason for Recall: Pouch containing pediatric probes was labeled as containing adult probes.
• FDA Determined 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.
• 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