BD Bodyguard Microset
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
BD Bodyguard Microset |
All lots. |
120-160XYSK |
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
Additional information
Details
Caesarea Medical Electronics Ltd.
16 Shacham Street, Caesarea, Israel, 3088900
Get notified
Receive notifications for new and updated recalls and alerts by category.