Bio-Detek Recalls Medsolutions4U Multi-Function Electrodes Due to Connector Defect
Bio-Detek, Inc. is recalling Medsolutions4U Multi-Function Electrodes because an incorrect wire connector prevents them from interfacing with PhysioControl Lifepak Defibrillators.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that prevents the device from functioning as intended for critical life-saving procedures (defibrillation/cardioversion). While no injuries are reported, the inability to use the device in an emergency constitutes a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Bio-Detek, Inc. is recalling Medsolutions4U Multi-Function Electrodes, Part Number 2033, manufactured with an incorrect wire connector. The defect prevents the electrodes from properly interfacing with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, and 500.
The recalled product is indicated for defibrillation, cardioversion, pacing, and monitoring. The recall involves 30 cases (300 electrodes) from Lot #0413, with an expiration date of January 26, 2015. The products were distributed worldwide in Germany and Slovenia.
Users should stop using the affected electrodes and contact Bio-Detek, Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- Bio-Detek, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #0413 Expiration Date: 2015-01-26
Distribution
Distribution scope not specified by the agency.
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