Recall Z-2565-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Bio-Detek, Inc.
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
| Date | Sep 2, 2014 (initiated Mar 12, 2013) |
| Status | Terminated |
| Reason | Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 30 cases (300 electordes) |
| Distribution | Worldwide Distribution in Germany and Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR Bio-Detek, Inc., Feb 27, 2004 |