Recall Z-2565-2014
Bio-Detek, Inc. · initiated March 12, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot #0413 Expiration Date: 2015-01-26
Reason for recall
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2565-2014
- Initiated
- March 12, 2013
- Posted by FDA
- September 2, 2014
- Terminated
- June 17, 2015
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 30 cases (300 electordes)
- Distribution
- Worldwide Distribution in Germany and Slovenia.
- Recalling firm
- Bio-Detek, Inc., Pawtucket, RI