SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: In

FDA device recall Z-0189-2014 · posted 2013-11-08 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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.

Action taken

Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 24, 2013 to all affected customers via first class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate the affected product, remove them from use and acknowledge your receipt of the recall notification by completing the provided Customer Reply Form and fax to 224-270-5467. Customers were asked to contact Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday during the hourse of 7:00 am and 7:00 pm Eastern Time to order replacement device(s). For technical questions contact Baxter Healthcare Medina at 800-356-3454, (choose option1) and for clinical questions contact Medical Information Services at Baxter 800-933-0303.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FRN

Quantity 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 Cana

Date initiated

2013-09-24

Date posted

2013-11-08

Date terminated

2016-11-09

Location

Deerfield, IL

Related 510(k) clearances