Public recall detail

BD Bodyguard Microset

2024-03-06

medium
Recall Safety notice
Quick summary

Quick summary: BD Bodyguard Microset. Date: 2024-03-06.

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: 2024-03-06.

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 I
IdentificationRA-75184

Affected products

ProductBD Bodyguard Microset
LotMore than 10 numbers, contact manufacturer.
Model120-160XCSK
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBD Bodyguard Microset

Issue

BD received customers complaints, that the new clamp on the y-port of the BD Bodyguard™ Microset (clamp supplied since 2021) can be opened more easily compared to the clamp which was used before 2021. Patients may accidentally lay on the infusion set and unintentionally open the clamp causing the infusion set to be exposed to atmospheric air/ environment, if a vented clamp is being used. The longer this failure mode remains undetected the higher the potential volume of air entry. Recall start date: February 26, 2024

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 I
Alert / recall typeHealth product recall
Identification numberRA-75184
Background{}
CompaniesCaesarea Medical Electronics Ltd. 16 Shacham Street, Caesarea, Israel, 3088900
AudiencesHealthcare
Source updated2024-03-06

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

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