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Health Canada Medical devices

Adult Manual Resuscitator

Issued May 16, 2025
Issue
Medline was informed by its contract manufacturer that the Adult Manual Resuscitator with mask, bag reservoir, and filter, CPRM1116F, was misassembled. Instead of the filter pre-attached at the exhalation port, it was connected to the patient port where the mask attaches. If the filter is incorrectly attached and not noticed before patient use, there could be a potential delay in patient resuscitation, which may result in life-threatening consequences, including hypoxia, hypercapnia, organ failure or death. Recall Start Date: May 9, 2025
Hazard description
Performance
Product
Product name
Adult Manual Resuscitator
Reference
ID
RA-77464