Product Wiki · Recalls · Health Canada — Medical Devices

CME BodyGuard Infusion Pump System (2020-03-06) — recall 61315

Health Canada — Medical Devices · Canada · 2020-06-02 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
61315
Date of alert
2020-06-02
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The current labeling for the BodyGuard pump indicates a flow rate range of 0.1-1200ml/hr, and an accuracy of +-5%. CMEA has recently completed internal testing to evaluate the flow rate accuracy across the labeled flow range. Results indicate that pumps may have a delivery inaccuracy of up to 13%.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cme-bodyguard-infusion-pump-sy

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