Colleague Infusion Pumps (2013-09-16)

Starting date:

September 16, 2013

Posting date:

October 28, 2013

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-36449

• 
  Reason
• 
  Affected products

Recalled Products

A. Colleague Volumetric Infusion Pump

B. Colleague 3 Volumetric Infusion Pump

C. Colleague Guardian Enhance CXE Color

D. Colleague Guardian Enhanced 3 CXE Color

E. French Colleague CXE Volumetric Pump

F. French Colleague 3 CXE Volumetric Pump

Reason

Baxter will commence a remediation strategy whereby all current Colleague pump customers will be provided with a newly manufactured Colleague P1.7A pump, software version 8.01.90 (EN) or 8.11.90 (FR) in exchange for each existing pump with an earlier software version. This remediation is being conducted to correct pump issues previously communicated on January 29, 2009 (Recall number 45280, Baxter reference 2008FCA18) and to provide other software and mechanical upgrades.

Affected products