FDA-Device2014-09-10Class II
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
Bio-Detek, Inc.
Hazard
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
Sold states
Worldwide Distribution in Germany and Slovenia.
Affected count
30 cases (300 electordes)
Manufactured in
525 Narragansett Park Dr, Pawtucket, RI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2565-2014Don't want to check this manually?
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