CanadaBD Alaris syringe pumps (models 8002MED01-G, 8002TIG01-G, 8002TIG03-G, 8005PK201, 8005TIG01, 8005TIG03, 8003TIG01-G, 8003TIG03-G, 8003MED01-G) and units with serial/lot numbers longer than 10 digits are affected. An internal mechanical anomaly of the linear potentiometer, which can occur if the device is not stored in the correct position, can cause incorrect sensor readings that trigger PL3, PL8 or PL9 error codes; these errors illuminate a red beacon, sound a high‑priority alarm and will stop an infusion. Contact the manufacturer for additional information.
What's being recalled
Companies: Bd Switzerland Sarl, Route De Crassier 17, Eysins, Switzerland, 1262.
How to identify it
Affected products: BD Alaris GH Plus Guardrails Syringe Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8002MED01-G
Affected products: BD Alaris GH Plus Guardrails Syringe Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8002TIG01-G
Affected products: BD Alaris GH Plus Guardrails Syringe Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8002TIG03-G
Affected products: BD Alaris PK Plus Syringe Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8005PK201
Affected products: BD Alaris PK Plus Syringe Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8005TIG01
Affected products: BD Alaris PK Plus Syringe Pump; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8005TIG03
Affected products: BD Alaris CC Guardrails Syringe Pump With Plus Software; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8003TIG01-G
Affected products: BD Alaris CC Guardrails Syringe Pump With Plus Software; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8003TIG03-G
Affected products: BD Alaris CC Guardrails Syringe Pump With Plus Software; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8003MED01-G
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States