Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15
FDA device recall Z-2565-2014 · posted 2014-09-02 · Terminated
Recall details
- Recalling firm
- Bio-Detek, Inc.
- Reason for recall
- Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
- Action taken
- 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
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 30 cases (300 electordes)
- Distribution
- Worldwide Distribution in Germany and Slovenia.
- Date initiated
- 2013-03-12
- Date posted
- 2014-09-02
- Date terminated
- 2015-06-17
- Location
- Pawtucket, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR (K033771) | Bio-Detek, Inc. | 2004-02-27 |