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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-1185-03
Recall Event ID 26988
510(K)Number K905446  
Product Classification Electrode, Electrocardiograph - Product Code DRX
Product 1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1690-001 (1 unit per pouch/30 per box); 1690-003 (3 units per pouch/30 per box); 1690-005 (5 units per pouch/50 per box); 1690-010 (50 units per pouch/no box/ 1000 per case); 1690-030 (30 units per pouch/no box). The above are sold in boxes of 600 with the exception of 1690-010 (sold 1000 per case) as noted above.

Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York
Code Information Cat No 1690-001: 0306092, 0306201, 0306202. Cat No 1690-003: 0305231, 0305232, 0306201. Cat No 1690-005: 0305162, 0305221, 0305301, 0306031, 0306042, 0306051, 0306191, 0306252, 0306301. Cat No 1690-010: 0305231, 0306171. Cat No 1690-030: 0305281, 0306031, 0306051, 0306101, 0306131, 0306161, 0306231, 0306232, 0306261
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 774,400 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 = MEDTRONIC ANDOVER MEDICAL, INC.
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