Product Wiki · Recalls · Health Canada — Medical Devices

Infant/Child Reduced Energy Defibrillation Electrode (2020-05-04) — recall 61287

Health Canada — Medical Devices · Canada · 2020-05-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61287
Date of alert
2020-05-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/infantchild-reduced-energy-def

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