—#28953

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

FDA product code: DRX — Electrode, Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K905446
Affected lot / code info: 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

Why it was recalled

Separation of the sensing element from the body of the electrode.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.

Recalling firm

Firm: Conmed Corporation
Address: 525 French Road, Utica, New York 13502

Distribution

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 .

Timeline

Recall initiated: 2003-07-30
Posted by FDA: 2003-08-27
Terminated: 2005-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28953. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.