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

• 
  Reason
• 
  Affected products

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