CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report

Medsolutions4U Multi-Function Electrodes to be used recalled

Bio-Detek is recalling Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak. The recall was initiated on 12 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #0413 Expiration Date: 2015-01-26
Quantity recalled30 cases (300 electordes)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2565-2014
FDA event ID
68970
Recalling firm
Bio-Detek, Pawtucket, RI
Classification
Class II
Status
Terminated
Recall initiated
12 Mar 2013
FDA classified
2 Sep 2014
Reported
10 Sep 2014
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

12 Mar 2013Recall initiated by company
2 Sep 2014Classified by FDA+539 days
10 Sep 2014Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution in Germany and Slovenia.

Questions about this recall

Is Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak recalled?

Yes. Bio-Detek recalled Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak on 12 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-2565-2014.

Why was it recalled?

Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

Which lots are affected?

Lot #0413 Expiration Date: 2015-01-26

Where was it sold?

Worldwide Distribution in Germany and Slovenia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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