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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