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Bd bodyguard microset
Official notice
15 Mar 2023
Last checked
15 Mar 2023
An official Health Canada notice concerns Bd bodyguard microset. 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 Published 2023-03-15.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73325
Official notice
2023-03-15
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Caesarea Medical Electronics, Bd Bodyguard Microset.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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