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Health product recall

Alaris PCA and Syringe Module Models (2017-11-23)

Starting date:
November 23, 2017
Posting date:
December 8, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-65352

Affected products

A. ALARIS PCA MODULE MODEL 8120
B. ALARIS SYRINGE MODULE MODEL 8110

Reason

The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. It is important to note that the syringe plunger gripper can be manually closed by the user. If the user follows the Alaris system user manual and ensures the syringe plunger gripper is closed there is no risk of harm to the patient. If however, the gripper is not closed around the syringe, there is a negligible risk of siphoning.

Affected products

A. ALARIS PCA MODULE MODEL 8120

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

8120

Companies
Manufacturer
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
UNITED STATES

B. ALARIS SYRINGE MODULE MODEL 8110

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

8110

Companies
Manufacturer
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
UNITED STATES