—#106249

Product

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 patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.

FDA product code: LDD — Dc-Defibrillator, Low-Energy, (Including Paddles)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K964469
Affected lot / code info: Lot 1006284

Why it was recalled

The product lot was assembled with an R2 Connector, rather than a Zoll Connector.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Road, Utica, New York 13502

Distribution

Distribution pattern: Nationwide Distribution-including the states of AZ, CA, IN, and MI.

Timeline

Recall initiated: 2011-03-09
Posted by FDA: 2012-01-12
Terminated: 2012-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106249. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.