Alaris System (2020-06-30)
- Starting date:
- June 30, 2020
- Posting date:
- July 17, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73555
Last updated:
2020-07-17
Affected Products
- Alaris System - ID Module
- Alaris System - Server Mobile Systems Manager
- Alaris System - PCA Module
- Alaris System - Entidal CO2 Module
- Alaris System - Pump
- Alaris System - SpO2 Module
- Alaris System - Syringe Pump Module
Reason
Recall is being initiated to notify customers of the following four hardware situations that require user attention and actions:
- damaged inter-unit-interface (IUI) connectors,
- broken elements on the Alaris Pump Module platen,
- improperly secured PC unit battery, and
- dim segment.
Affected products
A. Alaris System - ID Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8.4.5.0
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
B. Alaris System - Server Mobile Systems Manager
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8000
8015
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
C. Alaris System - PCA Module
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
California
UNITED STATES
D. Alaris System - Entidal CO2 Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8300
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
E. Alaris System - Pump
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8100
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
F. Alaris System - SpO2 Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8210
8220
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
G. Alaris System - Syringe Pump Module
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
California
UNITED STATES