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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 30, 2003
Date PostedAugust 27, 2003
Recall Status1 Terminated 3 on March 21, 2005
Recall NumberZ-1184-03
Recall Event ID 26988
510(K)NumberK991105 
Product Classification Electrode, Electrocardiograph - Product Code DRX
Product1680 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 ContactSandra Flack
315-624-3080
Manufacturer Reason
for Recall		Separation of the sensing element from the body of the electrode.
FDA Determined
Cause 2		Other
ActionLetters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.
Quantity in Commerce200,412 electrodes (# corrected 9/5/03)
Distribution241 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 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 = DRX
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