Product Wiki · Recalls · Health Canada — Medical Devices

5008 Cordiax HD-PAED option (2018-06-26) — recall 58084

Health Canada — Medical Devices · Canada · 2018-07-13 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
58084
Date of alert
2018-07-13
Country / jurisdiction
Canada
Authority classification
Type I
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: In the unlikely event of a leakage in the hydraulic system, balancing errors of up to 125 ml/h are possible. For patients < 17 kg body weight this could potentially lead to circulatory dysregulation with potential overhydration or underhydration and subsequent impact on cardiovascular stability.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/5008-cordiax-hd-paed-option-20

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