PlainRecalls
FDA Devices Moderate Class II Terminated

SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

Reported: November 20, 2013 Initiated: September 24, 2013 #Z-0189-2014

Product Description

SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

Reason for Recall

Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
346 units
Distribution
Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.. Recalled by Baxter Healthcare Corp.. Units affected: 346 units.
Why was this product recalled?
Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0189-2014.