Z-0055-2015Class II

ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number...

Name: Z-0055-2015 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number...
Creator: Bio-Detek, Inc.
Published: 2014-09-16
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2014-09-16 / Terminated / root cause: manufacturing process

FDA source

Bio-Detek, Inc. began a recall of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are... on 2014-09-16. FDA classified it as Class II and gives the reason as "Product sterility 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-0055-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-16
Posted: 2014-10-09
Terminated: 2016-05-03
Recalling firm: ZOLL Medical Corporation
Product: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Product sterility is not assured
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Bio-Detek notiifed customers of the expanded recall on September 16, 2014 for Lot 1914 and September 22, 2014 for Lots 1614, 1814, 2114 via UPS overnight delivery. Customers were requested to return the suspect product(s) in their possession. A Device Correction Response Return Form was provided to each Customer. For questions call 1-800-348-9011 or 1-978-421-9460.
Quantity in commerce: 41 singles
Distribution: Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
Product codes and lots: Lot Numbers: 1614, 1914, 2114

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0055-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0052-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0053-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0054-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08
Z-0055-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-08

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)