Health product recall

BD Bodyguard Microset

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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