Health product recall

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

Last updated

Summary

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

Alaris™ EtCO2 Module

More than 10 numbers, contact manufacturer.

8300

Alaris™ PCA Module

More than 10 numbers, contact manufacturer.

8120

BD Alaris™ Syringe Module

More than 10 numbers, contact manufacturer.

8110

BD Alaris™ Pump Module

More than 10 numbers, contact manufacturer.

8100

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Carefusion 303, Inc.

10020 Pacific Mesa Blvd., San Diego, California, United States, 92121-2733

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75992

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