Health product recall

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

  1. Alaris System - ID Module
  2. Alaris System - Server Mobile Systems Manager
  3. Alaris System - PCA Module
  4. Alaris System - Entidal CO2 Module
  5. Alaris System - Pump
  6. Alaris System - SpO2 Module
  7. 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:

  1. damaged inter-unit-interface (IUI) connectors,
  2. broken elements on the Alaris Pump Module platen,
  3. improperly secured PC unit battery, and
  4. 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