Recall Z-0735-2012 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
ConMed Corporation
R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. 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
| Date | Jan 12, 2012 (initiated Mar 9, 2011) |
| Status | Terminated |
| Reason | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. |
| Root cause | Packaging process control |
| Action | ConMed Corporation sent an "URGENT: DEVICE RECALL" letter dated March 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to stop use of the devices immediately. A Business Reply Form was attached for customers to complete and return to the firm via fax to 315-624-3225. Additionally, instructions were provided on how to return the affected devices. Contact the ConMed Recall Coordinator at 315-624-3237 for questions regarding this notice. |
| Quantity | 190 sets (2 pads per set in individual pouch) |
| Distribution | Nationwide Distribution-including the states of AZ, CA, IN, and MI. |
| 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 |