Health product recall

SIGMA Spectrum Infusion Pump with Master Drug Library (2018-05-15)

Starting date:
May 15, 2018
Posting date:
May 25, 2018
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-66882

Affected products

Reason

Baxter Corporation will be updating the Instructions For Use (IFU) of the sigma spectrum infusion system to instruct users to lower the primary bag approximately 12.5 inches below the secondary bag when performing a secondary infusion.

Affected products

SIGMA Spectrum Infusion Pump with Master Drug Library

Lot or serial number

More than 1000 numbers, contact manufacturer.

Model or catalog number

35700BAX

35700BAX2

Companies
Manufacturer

Baxter Healthcare Corporation

711 Park Ave.

Medina

14103

New York

UNITED STATES