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Health product recall

Central Water Plant Reverse Osmosis Units (CWP 100 and 60) (2016-11-23)

Starting date:
November 23, 2016
Posting date:
December 5, 2016
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-61312

Affected Products

A. Central Water Plant Reverse Osmosis Unit (CWP 100)
B. Central Water Plant Reverse Osmosis Unit (CWP 60)

Reason

Baxter Corporation is issuing a device correction for specific models of the central water plant (CWP) reverse osmosis units in order to correct the insufficient crimping of the cables within the main pump. The issue was identified as a result of customer complaints received for the presence of smoke in the water treatment room due to the overheating of the pump in the CWP. As part of Baxter's investigation, based on pictures provided from the event, the most likely cause of the thermal event was due to the crimp of the cables for the main pump being insufficient. To minimize any potential side effects of thermal events, please ensure all panels of the CWP are in place.

Affected products

A. Central Water Plant Reverse Osmosis Unit (CWP 100)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

WRO 104S
WRO 106H
WRO 106S
WRO101H
WRO101H(P)
WRO101S
WRO102H
WRO102H(P)
WRO102S
WRO103H
WRO103H(P)
WRO103S
WRO104H
WRO111
WRO112
WRO113
WRO114

Companies
Manufacturer
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN

B. Central Water Plant Reverse Osmosis Unit (CWP 60)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

WRO63

Companies
Manufacturer
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN