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Health Canada Medical devices

BD Bodyguard Microset

Issued March 15, 2023
Issue
This recall is being initiated to notify customers that BD has identified internally through a product review that the BD Bodyguard™ Microsets do not currently have the evidence to support compliance with ethylene oxide (eo) residual level requirements (per ISO 10993-7:2008/amd. 1:2019) for use in special populations, specifically children, infants, neonates and pre-mature neonates. Therefore, these devices are currently being limited in use with adults until the compliance evidence is gathered. Recall start date: February 13, 2023
Hazard description
Performance
Product
Product name
BD Bodyguard Microset
Reference
ID
RA-73325