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Health Canada Medical devices

BD Bodyguard Microset

Issued March 6, 2024
Issue
BD received customers complaints, that the new clamp on the y-port of the BD Bodyguard™ Microset (clamp supplied since 2021) can be opened more easily compared to the clamp which was used before 2021. Patients may accidentally lay on the infusion set and unintentionally open the clamp causing the infusion set to be exposed to atmospheric air/ environment, if a vented clamp is being used. The longer this failure mode remains undetected the higher the potential volume of air entry. Recall start date: February 26, 2024
Hazard description
Performance
Product
Product name
BD Bodyguard Microset
Reference
ID
RA-75184