Product Wiki · Recalls · Health Canada — Medical Devices

CME America BodyGuard Infusion Administration Sets (2020-06-16) — recall 61733

Health Canada — Medical Devices · Canada · 2020-10-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61733
Date of alert
2020-10-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Testing on tube sets revealed that some infusion sets do not meet the ±5% delivery accuracy level of the system or the ±13% accuracy level identified in Health Canada Incident #201656; therefore, the use of the pump system could cause over-infusion or under-infusion of therapy and patient harm.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cme-america-bodyguard-infusion

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