Health product recall

Alaris System - PCA & Syringe Pump Module (2020-08-05)

Starting date:
August 5, 2020
Posting date:
August 28, 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-73785



Last updated:
2020-08-28

Affected Products

  1. Alaris System - PCA Module
  2. Alaris System - Syringe Pump Module

Reason

Recall is being initiated to notify customers that the damage to the syringe barrel clamp mechanism on either the Alaris Syringe Module or Alaris PCA Module may result in the Alaris PC Unit displaying incorrect syringe types and/or sizes and that this issue could potentially result in delays in infusion, under-infusion, or over-infusion.

Affected products

A. 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


B. Alaris System - Syringe Pump Module

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 8110
  • 8110 RECONDITIONED
Companies
Manufacturer

Carefusion 303, Inc.

10020 Pacific Mesa Blvd.

San Diego

92121-2733

California

UNITED STATES