Z-1184-03

1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a...

Name: Z-1184-03 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a...
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 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are... 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-1184-03
Status: Terminated
Initiated: 2003-07-30
Posted: 2003-08-27
Terminated: 2005-03-21
Recalling firm: ConMed Corporation
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
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: 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 .
Product codes and lots: Cat No. 1680-001: 0305301, 0306091, 0306092. Cat No. 1680-003: 0306241. Cat No. 1680-005: 0306042. Cat No. 1680-030: 0306021, 0306051.

Product code DRX

K991105Class IIECG Electrode (Various)Conmedcorp / cleared 1999-11-26

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)