| Class 3 Device Recall Dry Reference pH Probe. |  |
Date Initiated by Firm | January 08, 2003 |
Date Posted | January 23, 2003 |
Recall Status1 |
Terminated 3 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
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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
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Manufacturer Reason for Recall | Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication. |
FDA Determined Cause 2 | 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 |
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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
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