Public recall detail

BD Bodyguard Microset

2023-03-15

medium
Recall Safety notice
Quick summary

Quick summary: BD Bodyguard Microset. Date: 2023-03-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BD Bodyguard Microset. Date: 2023-03-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCaesarea Medical Electronics Ltd.
ProductBD Bodyguard Microset
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73325

Affected products

ProductBD Bodyguard Microset
LotAll lots.
Model120-160XYSK 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
Serial numberAll lots.
DescriptionBD Bodyguard Microset

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesCaesarea Medical Electronics Ltd. 16 Shacham Street, Caesarea, Israel, 3088900
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73325
Background{}
CompaniesCaesarea Medical Electronics Ltd. 16 Shacham Street, Caesarea, Israel, 3088900
AudiencesHealthcare
Source updated2023-03-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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