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
This recall has been terminated (originally issued September 2, 2014).
- Company
- Bio-Detek, Inc.
- Recall Initiated
- March 12, 2013
- Posted
- September 2, 2014
- Terminated
- June 17, 2015
- Recall Number
- Z-2565-2014
- Quantity
- 30 cases (300 electordes)
- Firm Location
- Pawtucket, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
Distribution
Worldwide Distribution in Germany and Slovenia.
Lot / Code Info
Lot #0413 Expiration Date: 2015-01-26
Root 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.
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