Recall Z-1184-03 ยท DRX Electrode, Electrocardiograph
Conmed Corporation
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
| Date | Aug 27, 2003 (initiated Jul 30, 2003) |
| Status | Terminated |
| Reason | Separation of the sensing element from the body of the electrode. |
| Root cause | Other |
| Action | Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors. |
| Quantity | 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 . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991105 | ECG ELECTRODE (VARIOUS) Conmedcorp, Nov 26, 1999 |