Z-1317-2013Class II

PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult...

Name: Z-1317-2013 PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult...
Creator: ConMed Corporation
Published: 2013-05-03
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2013-05-03 / Terminated / root cause: design

FDA source

ConMed Corporation began a recall of PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon... on 2013-05-03. FDA classified it as Class II and gives the reason as "ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1317-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-03
Posted: 2013-05-13
Terminated: 2015-08-25
Recalling firm: ConMed Corporation
Product: PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.
Root cause tag: design
FDA root cause: Component design/selection
Action: ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, 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 please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please call 1 315-624-3237 or fax to +1 315-624-3225.
Quantity in commerce: Domestic: 49,010; Foreign: 600
Distribution: Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia.
Product codes and lots: Lot Code Y092012-21, Manufacture Date 10/10/2012; Lot Code Y102612-12, Manufacture Date 11/17/2012; Lot Code Y110912-20, Manufacture Date 11/30/2012; Lot Code Y112912-10, Manufacture Date 12/22/2012; Lot Code Y121312-19, Manufacture Date 01/03/2013; Lot Code Y011013-13, Manufacture Date 01/29/2013; Lot Code Y012513-02, Manufacture Date 02/12/2013; Lot Code Y020713-05, Manufacture Date 02/26/2013; Lot Code Y021413-03, Manufacture Date 03/07/2013; Lot Code Y030113-04, Manufacture Date 03/23/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1317-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-13

Product code MKJ

K014209Class IIIPadpro Model 2001, 2001-S, 2001-C, 2001-EpsPadpro, LLC / cleared 2002-01-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)