Class 3 Device Recall Dry Reference pH Probe.

• Date Initiated by Firm: January 08, 2003
• Date Posted: January 23, 2003
• Recall Status: Terminated on April 16, 2003
• Recall Number: Z-0466-03
• Recall Event ID: 25364
• 510(K)Number: K931963
• Product Classification: Electrode, Ph, Stomach - Product Code FFT
• Product: ''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Sandhill Scientific, Inc; 9150 Commerce Center Circle, #500; Highlands Ranch CO 80129
• Manufacturer Reason for Recall: Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
• FDA Determined 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.
• 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.