Infant/Child Reduced Energy Defibrillation Electrode (2020-05-04)

Starting date:

May 4, 2020

Posting date:

May 22, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73161

Last updated: 2020-05-22

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  Reason
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  Affected products

Affected Products

Infant/Child Reduced Energy Defibrillation Electrode

Reason

Through the product complaint program, Stryker has become aware that certain packages of infant child reduced energy electrodes produced by Cardinal Health, Inc. May have compromised seals. The compromised packaging seal has the potential to result in the electrodes becoming dried out. This could result in inadequate adhesion to patient, failure of the defibrillator to detect patient connection, ineffective or no energy delivered to patient, or patient burns. There have been no patient related occurrences with this issue.

Affected products