Recall Z-1185-03 ยท DRX Electrode, Electrocardiograph
Conmed Corporation
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 i
| 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 | 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 . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905446 | MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE Medtronic Andover Medical, Inc., Feb 5, 1991 |