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Class 2 Device Recall Singleuse grounding pad. |
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Date Initiated by Firm |
July 16, 2003 |
Date Posted |
August 12, 2003 |
Recall Status1 |
Terminated 3 on February 18, 2004 |
Recall Number |
Z-1121-03 |
Recall Event ID |
26842 |
510(K)Number |
K000079
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Product Classification |
Apparatus, Electrosurgical - Product Code HAM
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Product |
Radionics Disposable Grounding Plate |
Code Information |
Catalog Number DGP-HP. |
Recalling Firm/ Manufacturer |
Valleylab, Inc 5920 Longbow Drive Boulder CO 80301
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For Additional Information Contact |
303-530-6241
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Manufacturer Reason for Recall |
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
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FDA Determined Cause 2 |
Other |
Action |
Users were notified by letter on 7/16/2003. |
Quantity in Commerce |
25000 pads |
Distribution |
Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan. |
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 = HAM and Original Applicant = NIKOMED U.S.A., INC.
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