1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. E
FDA device recall Z-1185-03 · posted 2003-08-27 · Terminated
Recall details
- Recalling firm
- Conmed Corporation
- Reason for recall
- Separation of the sensing element from the body of the electrode.
- Action taken
- Letters dated 7/30/03 requesting return of recalled lots and subrecall by distributors.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRX
- Quantity affected
- 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
- Date initiated
- 2003-07-30
- Date posted
- 2003-08-27
- Date terminated
- 2005-03-21
- Location
- Utica, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE (K905446) | Medtronic Andover Medical, Inc. | 1991-02-05 |