Z-1185-03

1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use...

Name: Z-1185-03 1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use...
Creator: Conmed Corporation
Published: 2003-07-30
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2003-07-30 / Terminated

FDA source

Conmed Corporation began a recall of 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... on 2003-07-30. The reason FDA records is "Separation of the sensing element from the body of the electrode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1185-03
Status: Terminated
Initiated: 2003-07-30
Posted: 2003-08-27
Terminated: 2005-03-21
Recalling firm: ConMed Corporation
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
Product code: DRX Electrode, Electrocardiograph
Reason for recall: Separation of the sensing element from the body of the electrode.
FDA root cause: 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 .
Product codes and lots: 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

Product code DRX

K905446Class IIMeditronic Andover Medical Model 1690 ElectrodeMedtronic Andover Medical, Inc. / cleared 1991-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)