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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 30, 2003
Date Posted August 27, 2003
Recall Status1 Terminated 3 on March 21, 2005
Recall Number Z-1184-03
Recall Event ID 26988
510(K)Number K991105  
Product Classification Electrode, Electrocardiograph - Product Code DRX
Product 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case.

Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York
Code Information Cat No. 1680-001: 0305301, 0306091, 0306092. Cat No. 1680-003: 0306241. Cat No. 1680-005: 0306042. Cat No. 1680-030: 0306021, 0306051.
Recalling Firm/
Manufacturer		 Conmed Corporation
525 French Road
Utica NY 13502
For Additional Information Contact Sandra Flack
315-624-3080
Manufacturer Reason
for Recall		 Separation of the sensing element from the body of the electrode.
FDA Determined
Cause 2		 Other
Action Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.
Quantity in Commerce 200,412 electrodes (# corrected 9/5/03)
Distribution 241 direct accounts including wholesalers and medical facilities. Of these, there are 15 foreign consignees in Canada, Belgium, Germany, Norway, The Netherlands, Spain, United Kingdom, Japan, Malaysia, Thailand, and United Arab Emirates .
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 = DRX and Original Applicant = CONMED CORP.
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