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Health Canada Medical devices

Poches A Sang Quadruple

Issued May 24, 2022
Issue
Macopharma noticed, since the beginning of 2022, an increasing rate of failed leucodepletion results of devices containing lcrd2 filters, the frequency is currently between 0.0001%-0.08% depending on the customer, to breakages within the internal welding of the filtering mattress after the centrifugation step within a small number of sites in some countries. This may occur during the customer processing following an unfavourable positioning of the filter inside the centrifugation bucket. Recall start date: May 12, 2022
Hazard description
Performance
Product
Product name
Poches A Sang Quadruple
Reference
ID
RA-64190