BD Bodyguard Microset
Brand(s)
Last updated
Summary
Product
BD Bodyguard Microset
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| BD Bodyguard Microset | All lots. | 120-160XYSK ONC00005 100-160XSMG90EK 120-112XPEFKY EPI00011-NRF PCA00001 TPN00005 100-163XE90SK 100-163XESK 100-163XESVK 100-184XSYK 120-160XCSEK 120-160XSFMK EPI00003 ONC00004UV 120-003XS2YV PCA00004 100-163XNKS 120-160XCSK EPI00012-NRF 100-184XSK TPN00004 101-163XE90SK 120-112XSFK 120-112XSFVK 120-160X90SK ONC00006 PCA00002 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Caesarea Medical Electronics Ltd.
16 Shacham Street, Caesarea, Israel, 3088900
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73325
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