Product Wiki · Recalls · Health Canada — Medical Devices

NexSys PCS 300/ PCS2 Plasma Collection System — recall 64417

Health Canada — Medical Devices · Canada · 2022-08-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64417
Date of alert
2022-08-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Gastroenterology and urology - Haematology
Product type
Medical devices
Reported risk: A software defect is present where in the case that the customer is running on smart last cycle, and a procedure is aborted or has an unrecoverable interruption, the red blood cell loss estimation flag may not be accurate, and should not be used as the basis for donor deferral in the case of RBC loss. Recall start date: July 15, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/nexsys-pcs-300-pcs2-plasma-col

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