Z-2659-2014Class II

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes...

Name: Z-2659-2014 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes...
Creator: Bio-Detek, Inc.
Published: 2014-08-26
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2014-08-26 / Terminated / root cause: manufacturing process

FDA source

Bio-Detek, Inc. began a recall of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators... on 2014-08-26. FDA classified it as Class II and gives the reason as "Sterility of device is not assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2659-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-26
Posted: 2014-09-17
Terminated: 2016-05-03
Recalling firm: ZOLL Medical Corporation
Product: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Sterility of device is not assured
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BioDetek sent an Urgent Device Correction letter dated August 26, 2014, to all affected customers via UPS overnight delivery. There has also been notifications addressed to the 4 International accounts on August 27, 2014. Customers were requested to return the suspect product(s) in their possession and complete the Device Correction Response Return Form provided to each customer. Customer inventory will be replaced as soon as replacement electrodes are processed. Customers with questions can contact the technical support numbers at 1 (800) 348-9011 or +1 (978) 421-9460 24/7. For questions regarding this recall call 401-729-1400.
Quantity in commerce: 12 each
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Product codes and lots: Lot Number: 2314

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2659-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2658-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-17
Z-2659-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-17
Z-2660-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-17

Product code MKJ

K943698Class IIIStat Padz Sterile Adult Multi-Function ElectrodesZoll Medical Corp / cleared 1994-12-28

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)