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Health product recall

Coiled Tube Infusor (2014-03-05)

Starting date:
March 5, 2014
Posting date:
April 4, 2014
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-38793

Recalled Products

Coiled Tube Infusor

Reason

Baxter corporation has initiated an important product information communication regarding the coiled tube infusor system. Recent testing has shown that the nominal flow rate as labeled is achieved when the elastomeric reservoir is positioned 15 cm to 20 cm (6 to 8 inches) below the Distal Luer Lock and not when positioned at the same height as stated in the directions for use.

Affected products

Coiled Tube Infusor

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

2C1071KJP
2C1073KJP
2C1075KJP
2C1080KJP
2C1082KJP

Companies
Manufacturer
Baxter Healthcare Sa
Zurich
SWITZERLAND