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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgery cautery tip

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 Class 2 Device Recall Electrosurgery cautery tipsee related information
Date Initiated by FirmDecember 20, 2002
Date PostedJanuary 30, 2003
Recall Status1 Terminated 3 on September 05, 2003
Recall NumberZ-0469-03
Recall Event ID 25265
510(K)NumberK943055 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
ProductMegadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE
Code Information Catalog Number 0600M. Lots 00994, 01880, 01181, 01112, 10156, 10670, 11008, 11388, 20260, 20814.
Recalling Firm/
Manufacturer		 Megadyne Medical Products, Inc
11506 South State Street
Draper UT 84020
Manufacturer Reason
for Recall		The metal substrate cautery tip may break during use.
FDA Determined
Cause 2		Other
ActionOn 12/20/2002, all consignees were notified by letter to return all affected product.
Quantity in Commerce4855
DistributionNationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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