Z-0735-2012

R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN...

Name: Z-0735-2012 R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN...
Creator: ConMed Corporation
Published: 2011-03-09
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2011-03-09 / Terminated / root cause: packaging

FDA source

ConMed Corporation began a recall of R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY... on 2011-03-09. The reason FDA records is "The product lot was assembled with an R2 Connector, rather than a Zoll Connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0735-2012
Status: Terminated
Initiated: 2011-03-09
Posted: 2012-01-12
Terminated: 2012-01-12
Recalling firm: ConMed Corporation
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.
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: The product lot was assembled with an R2 Connector, rather than a Zoll Connector.
Root cause tag: packaging
FDA 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 in commerce: 190 sets (2 pads per set in individual pouch)
Distribution: Nationwide Distribution-including the states of AZ, CA, IN, and MI.
Product codes and lots: Lot 1006284

Product code LDD

K964469Class II700-F Series Stimulation ElectrodesCardiotronics Systems, Inc. / cleared 1996-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)