Physio-Control Recalls Infant Defibrillation Electrodes Due to Packaging Seal Issues
Physio-Control is recalling infant and child defibrillation electrodes because the packaging was not properly sealed. The recall affects units manufactured between August 2017 and October 2019.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging defect (improper sealing) with no reported illnesses or injuries, fitting the criteria for a moderate severity recall involving potential contamination or integrity issues without confirmed harm.
Plain-English summary
Physio-Control, Inc. is recalling Infant/Child Reduced Energy Defibrillation Electrodes, Part Number 3202380-006. These electrodes are intended for use with LIFEPAK 1000, LIFEPAK 500, and LIFEPAK CR Plus/EXPRESS defibrillators by trained personnel in emergency medical response systems.
The recall was initiated because the packaging of the electrodes was not properly sealed. The affected units were manufactured between August 2017 and October 2019 and have not yet reached their expiration date. The recall covers 118,689 units distributed worldwide, including nationwide distribution in the United States and various international locations.
Healthcare facilities and users should stop using the affected electrodes and contact Physio-Control for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation
- Manufacturer
- Physio-Control, Inc.
- Affected units
- 118,689
Distribution
Part of a larger recall action
This product is one of 2 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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