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
FDA Recall Z-1185-03 · Posted 2003-08-27
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Recalling FirmConmed Corporation
Recall StatusTerminated
Product CodeDRX
Date Initiated2003-07-30
Date Terminated2005-03-21
Product Quantity774,400 electrodes (# corrected 9/5/03)
Reason for Recall
Separation of the sensing element from the body of the electrode.
Firm Action
Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.
Root Cause
Other
Distribution Pattern
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 .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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