Z-2565-2014Class II

Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C...

Name: Z-2565-2014 Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C...
Creator: Bio-Detek, Inc.
Published: 2013-03-12
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2013-03-12 / Terminated / root cause: manufacturing process

FDA source

Bio-Detek, Inc. began a recall of Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for... on 2013-03-12. FDA classified it as Class II and gives the reason as "Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators". 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-2565-2014
Classification: Class II
Status: Terminated
Initiated: 2013-03-12
Posted: 2014-09-02
Terminated: 2015-06-17
Recalling firm: ZOLL Medical Corporation
Product: Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Bio-Detek issued an Urgent Field Safety Notice to Medsolutions4 U on 3/12/13, informing them of the problem and actions that should be taken to remove the affected products from service.
Quantity in commerce: 30 cases (300 electordes)
Distribution: Worldwide Distribution in Germany and Slovenia.
Product codes and lots: Lot #0413 Expiration Date: 2015-01-26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2565-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2565-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-02

Product code MKJ

K033771Class IIIBio-Detek Modified Adult Multi-Function Electrode with ConnectorBio-Detek, Inc. / cleared 2004-02-27

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)