Date Initiated by Firm | March 09, 2011 |
Date Posted | January 12, 2012 |
Recall Status1 |
Terminated 3 on January 12, 2012 |
Recall Number | Z-0735-2012 |
Recall Event ID |
60700 |
510(K)Number | K964469 |
Product Classification |
Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
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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. |
Code Information |
Lot 1006284 |
Recalling Firm/ Manufacturer |
ConMed Corporation 525 French Road Utica NY 13502
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For Additional Information Contact | M. Patricia Cotter 315-624-3533 |
Manufacturer Reason for Recall | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. |
FDA Determined Cause 2 | 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 in Commerce | 190 sets (2 pads per set in individual pouch) |
Distribution | Nationwide Distribution-including the states of AZ, CA, IN, and MI. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LDD
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