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Class 2 Device Recall Electrosurgery cautery tip |
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Date Initiated by Firm |
December 20, 2002 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on September 05, 2003 |
Recall Number |
Z-0468-03 |
Recall Event ID |
25265 |
510(K)Number |
K943055
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Product Classification |
Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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Product |
Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE |
Code Information |
Catalog Number 0600. Lots 00664, 00845, 10038, 10190, 10541, 10669, 10703, 10766, 10951, 11110, 11356, 20046, 20219, 20520, 20592, 20757, 20777, 20856, 20997, 21075. |
Recalling Firm/ Manufacturer |
Megadyne Medical Products, Inc 11506 South State Street Draper UT 84020
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Manufacturer Reason for Recall |
The metal substrate cautery tip may break during use.
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FDA Determined Cause 2 |
Other |
Action |
On 12/20/2002, all consignees were notified by letter to return all affected product. |
Quantity in Commerce |
19464 |
Distribution |
Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden. |
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 = GEI and Original Applicant = MEGADYNE MEDICAL PRODUCTS, INC.
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