Recall Z-2565-2014— Bio-Detek, Inc.
Class II · Terminated
Class II FDA medical device recall by Bio-Detek, Inc., initiated 2013-03-12, terminated 2015-06-17. It names one FDA 510(k) clearance: K033771. 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. Reason: Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators.
- Recalling firm
- Bio-Detek, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-12
- Terminated
- 2015-06-17
- Firm location
- Pawtucket, RI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
Data sourced from openFDA. This site is unofficial and independent of the FDA.