Z-0756-2007

PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring...

Name: Z-0756-2007 PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring...
Creator: Conmed Corporation
Published: 2007-03-08
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2007-03-08 / Terminated / root cause: packaging

FDA source

Conmed Corporation began a recall of PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for... on 2007-03-08. The reason FDA records is "Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not...". 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-0756-2007
Status: Terminated
Initiated: 2007-03-08
Posted: 2007-04-24
Terminated: 2012-07-16
Recalling firm: ConMed Corporation
Product: PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Utica, New York, 13502.
Product code: MLN Electrode, Electrocardiograph, Multi-Function
Reason for recall: Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.
Root cause tag: packaging
FDA root cause: Other
Action: On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by the same means. Returned devices will be automatically replaced by ConMed Corporation. A separate letter is being sent to the foreign accounts today instructing them to return the devices back to ConMed Corporation for final disposition. The letters also instruct the consignees to complete the accompanying reply form and fax it to Nancy Crisino at (315) 624-3089. ConMed has contracted Stericycle in Indianapolis, IN, to handle the recall and returns from the domestic accounts.
Quantity in commerce: 9712 pairs
Distribution: Worldwide, including USA, Canada, Romania, Chile, and Belgium
Product codes and lots: Lots Y040605-1, Y040605-2, Y052605-4, Y120805-2, Y111605-3, Y092805-6, Y010506-10, Y010506-9.

Product code MLN

K020203Class IIIPadpro Model #2516Padpro, LLC / cleared 2002-05-08

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)