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Terminated

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

FDA Recall Z-2565-2014 · Posted 2014-09-02

Recalling FirmBio-Detek, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2013-03-12
Date Terminated2015-06-17
Product Quantity30 cases (300 electordes)

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution in Germany and Slovenia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTORBio-Detek, Inc. · 2004-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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