Health product recall

BD Alaris™ Syringe Pumps

Last updated

Summary

Product
BD Alaris™ Syringe Pumps
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 catalogue number
BD Alaris GH Plus Guardrails Syringe Pump More than 10 numbers, contact manufacturer. 8002MED01-G
BD Alaris GH Plus Guardrails Syringe Pump More than 10 numbers, contact manufacturer. 8002TIG01-G
BD Alaris GH Plus Guardrails Syringe Pump More than 10 numbers, contact manufacturer. 8002TIG03-G
BD Alaris PK Plus Syringe Pump More than 10 numbers, contact manufacturer. 8005PK201
BD Alaris PK Plus Syringe Pump More than 10 numbers, contact manufacturer. 8005TIG01
BD Alaris PK Plus Syringe Pump More than 10 numbers, contact manufacturer. 8005TIG03
BD Alaris CC Guardrails Syringe Pump With Plus Software More than 10 numbers, contact manufacturer. 8003TIG01-G
BD Alaris CC Guardrails Syringe Pump With Plus Software More than 10 numbers, contact manufacturer. 8003TIG03-G
BD Alaris CC Guardrails Syringe Pump With Plus Software More than 10 numbers, contact manufacturer. 8003MED01-G

Issue

BD has identified through an internal investigation that the BD Alaris™ syringe pumps may develop a mechanical anomaly on the linear potentiometer if the device is not stored in the correct position. The syringe plunger moves along the linear potentiometer component during infusion. This is an internal component and not readily visible to the clinical user. If this anomaly occurs, it can lead to incorrect sensor readings, which may trigger error codes PL3, PL8, or PL9. These PL error codes are an intentional design feature that notify the clinical user that the syringe pump has detected an internal malfunction and can occur for a number of reasons.
The PL3/PL8/PL9 error codes result in the syringe pump issuing an error message along with a red illuminated beacon, and a high priority alarm tone. If an infusion is in progress, it will stop. The error code will be displayed on the syringe pump as <error code and message>, see below image example of a PL9 error code.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Bd Switzerland Sarl
Route De Crassier 17, Eysins, Switzerland, 1262
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81631

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