|
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
|
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 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
|
|
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.
|
|
|
|