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Class 3 Device Recall Disposable Internal Reference Impedance Probe |
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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
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Product Classification |
Electrode, Ph, Stomach - Product Code FFT
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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
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For Additional Information Contact |
303-470-7020
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Manufacturer Reason for Recall |
Pouch containing pediatric probes was labeled as containing adult probes.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = FFT and Original Applicant = SANDHILL SCIENTIFIC, INC.
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