Reported Sep 10, 2014 · Terminated
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12,…
Bio-Detek, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Detek, Inc. · 525 Narragansett Park Dr · Pawtucket, RI · 02861-4323
Is this the product you have?
- 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 Number2033
- Lot codes and dates
- Lot #0413
- Expiration Date2015-01-26
- Amount recalled
- 30 cases (300 electordes)
Why it was recalled
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
This product could cause temporary or reversible health problems — stop using it.
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