Health product recall

SIGMA SPECTRUM Infusion System (V8 Platform) (2021-03-17)

Starting date:
March 17, 2021
Posting date:
April 1, 2021
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-75287

Last updated:
2021-04-01

Affected Products 

SIGMA SPECTRUM Infusion System (V8 Platform)

Reason

Baxter is communicating important safety information regarding the practice of using multiple extension sets with infusion pumps. Increasing the length of IV tubing between the pump and the patient will result in varying increases in outlet pressure and/or decreases in intake pressure, which could lead to unknown and undetectable reductions in forward flow and flow rate accuracy.

Affected products

SIGMA SPECTRUM Infusion System (V8 Platform)

Lot or serial number
  • All serial numbers. 
Model or catalog number
  • 35700BAX2
Companies
Manufacturer

Baxter Healthcare Corporation

711 Park Ave.

Medina

14103

New York

UNITED STATES