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Health product recall

SIGMA SPECTRUM INFUSION PUMP W/MASTER DRUG LIBRARY (V6) (2017-10-04)

Starting date:
October 4, 2017
Posting date:
October 11, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-64818

Affected products

SIGMA SPECTRUM INFUSION PUMP W/MASTER DRUG LIBRARY (V6)

Reason

Baxter Corporation is issuing an urgent medical device correction for certain Sigma Spectrum Infusion pumps with Master Drug Library (v6) due to the potential that a small number of these pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication. This could potentially result in over- or under-infusion.

Affected products

SIGMA SPECTRUM INFUSION PUMP W/MASTER DRUG LIBRARY (V6)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

35700BAX

Companies
Manufacturer

Baxter Healthcare Corporation

711 Park Ave.

Medina

14103

New York

UNITED STATES