Recall Z-0856-2012 ยท MLN Electrode, Electrocardiograph, Multi-Function
ConMed Corporation
R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507 This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient
| Date | Jan 25, 2012 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | The specific lot was assembled without the rivet cover. |
| Root cause | Employee error |
| Action | ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I. If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225. Please complete the attached Business |
| Quantity | 850 sets (2 pads per set in individual pouch) |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Canada, Belgium, Germany and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964469 | 700-F SERIES STIMULATION ELECTRODES Cardiotronics Systems, Inc., Dec 11, 1996 |