Health product recall

Colleague P1.7 Large Volumetric Pump (LVP) (2021-03-04)

Starting date:
March 4, 2021
Posting date:
March 18, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-75149

Last updated: 2021-03-18

Affected Products 

A. COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
B. COLLEAGUE GUARDIAN ENHANCED 3 CXE COLOR PUMP
C. FRENCH COLLEAGUE CXE VOLUMETRIC PUMP
D. FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP

Reason

Baxter Corporation has identified that the Colleague P1.7 Large Volumetric Pump (lVP) Operator's Manual and Global Service Manual require updates to include flow rate accuracy claims for non DEHP administration sets. The current flow rate accuracy claims in the manuals are specific to DEHP administration sets.

Affected products

A. COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP

Lot or serial number

All serial numbers.

Model or catalog number

2M91617A

Companies
Manufacturer
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND

B. COLLEAGUE GUARDIAN ENHANCED 3 CXE COLOR PUMP

Lot or serial number

All serial numbers.

Model or catalog number

2M91637A

Companies
Manufacturer
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND

C. FRENCH COLLEAGUE CXE VOLUMETRIC PUMP

Lot or serial number

All serial numbers.

Model or catalog number

DNM91617A

Companies
Manufacturer
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND

D. FRENCH COLLEAGUE 3 CXE VOLUMETRIC PUMP

Lot or serial number

All serial numbers.

Model or catalog number

DNM91637A

Companies
Manufacturer
Baxter Healthcare SA
PO BOX 8010
Zurich
8010
SWITZERLAND