Public recall detail

BD Alaris™ EtCO2, PCA, Syringe, and Pump Modules

2024-08-30

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Recall Safety notice
Quick summary

Quick summary: BD Alaris™ EtCO2, PCA, Syringe, and Pump Modules. Date: 2024-08-30.

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 Alaris™ EtCO2, PCA, Syringe, and Pump Modules. Date: 2024-08-30.

Official details

Affected product details

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

BrandCarefusion 303, Inc.
ProductBD Alaris™ EtCO2, PCA, Syringe, and Pump Modules
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75992

Affected products

ProductAlaris™ EtCO2 Module
LotMore than 10 numbers, contact manufacturer.
Model8300
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlaris™ EtCO2 Module
ProductAlaris™ PCA Module
LotMore than 10 numbers, contact manufacturer.
Model8120
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlaris™ PCA Module
ProductBD Alaris™ Syringe Module
LotMore than 10 numbers, contact manufacturer.
Model8110
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBD Alaris™ Syringe Module
ProductBD Alaris™ Pump Module
LotMore than 10 numbers, contact manufacturer.
Model8100
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBD Alaris™ Pump Module

Issue

BD has identified an increase in bent contacts on new Female/Left IUI connectors on devices and spare parts manufactured between Jan 01, 2023 and June 06, 2024. BD was made aware of this issue through complaints identified during the device check-in process and has not received any reports of this issue occurring during patient use. A defective pin on certain Female/Left IUI connectors that are not detected prior to use could result in an inoperable device or an operable device where adjoining device cannot be powered on at start up. Recall Start Date: August 15, 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
CompaniesCarefusion 303, Inc. 10020 Pacific Mesa Blvd., San Diego, California, United States, 92121-2733
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75992
Background{}
CompaniesCarefusion 303, Inc. 10020 Pacific Mesa Blvd., San Diego, California, United States, 92121-2733
AudiencesHealthcare
Source updated2024-08-30

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

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