Alaris Pump Module Model 8100 (2018-04-10)

Starting date:

April 10, 2018

Posting date:

May 4, 2018

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-66700

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  Reason
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  Affected products

Affected products

Alaris Pump Module Model 8100

Reason

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.  This can result in under or over infusion to the patient. The affected bezel assembly was manufactured between September and December 2011.

Affected products