Health product recall

Alaris Pump Module, Model 8100 (2019-04-12)

Starting date:
April 12, 2019
Posting date:
May 17, 2019
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-69966



Last updated: 2019-05-17

Affected Products

Alaris Pump Module, Model 8100

Reason

This recall is an expansion to Recalls RA-64562 and RA-66700 to include bezels manufactured between April 2011 and June 2017. The component of the Alaris pump module mechanical assembly of concern is the bezel assembly, specifically the bezel posts. The affected mechanical assembly may have separation of one or more of the 6 posts that connect the mechanism frame to the bezel assembly, due to weakened plastic.

Affected products

Alaris Pump Module, Model 8100

Lot or serial number

All lots.

Model or catalog number

8100

Companies
Manufacturer

Carefusion 303, Inc.

10020 Pacific Mesa Blvd.

San Diego

92121-2733

California

UNITED STATES