Recalls / —
—#106250
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.
- FDA product code
- MLN — Electrode, Electrocardiograph, Multi-Function
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K964469
- Affected lot / code info
- Lot 1010194
Why it was recalled
The specific lot was assembled without the rivet cover.
Root cause (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- ConMed Corporation
- Address
- 525 French Road, Utica, New York 13502
Distribution
- Distribution pattern
- Worldwide Distribution -- USA (nationwide) and the countries of Canada, Belgium, Germany and Hong Kong.
Timeline
- Recall initiated
- 2011-03-31
- Posted by FDA
- 2012-01-25
- Terminated
- 2012-01-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #106250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.