Recall Z-0856-2012
ConMed Corporation · initiated March 31, 2011
Product
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 and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.
Codes / lots: Lot 1010194
Reason for recall
The specific lot was assembled without the rivet cover.
FDA-determined cause: Employee error
Action taken
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 reply form. We apologize for any inconvenience this will cause you or your staff. For further questions please call (315) 797-8375.
Details
- Recall number
- Z-0856-2012
- Initiated
- March 31, 2011
- Posted by FDA
- January 25, 2012
- Terminated
- January 26, 2012
- Product code
- MLN – Electrode, Electrocardiograph, Multi-Function
- 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.
- Recalling firm
- ConMed Corporation, Utica, NY