Physio-Control Recalls Infant Child Starter Kits Due to Packaging Seal Issues
Physio-Control is recalling 6,732 Infant Child Starter Kits because the packaging for the reduced energy electrodes was not properly sealed.
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 2/5 (Moderate).
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, and the hazard involves a packaging defect (improper sealing) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Physio-Control, Inc. is recalling 6,732 Infant Child Starter Kits, Part Number 3202784-009. These kits contain Infant/Child Reduced Energy Defibrillation Electrodes intended for use with LIFEPAK 1000, LIFEPAK 500, and LIFEPAK CR Plus/EXPRESS defibrillators. The affected electrodes were manufactured between August 2017 and October 2019 and have not yet reached their expiration date.
The recall was initiated because the packaging of the infant child reduced energy electrodes was not properly sealed. This defect could potentially compromise the integrity of the electrodes.
The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Canada, Australia, Japan, and Brazil. These devices are intended for use by personnel trained on device operation and in basic life support or other physician-authorized emergency medical response systems. Users should stop using the affected kits and contact Physio-Control for instructions on replacement or return.
The recalled product
- Product
- Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel…
- Manufacturer
- Physio-Control, Inc.
- Hazard
- Affected units
- 6,732
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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Similar recalls
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- HighInfant and child defibrillator electrodes recalled over pediatric electrode delamination
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