Recall Z-0189-2014— Baxter Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-09-24, terminated 2016-11-09. It names one FDA 510(k) clearance: K042121. Product: 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: 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..
- Recalling firm
- Baxter Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-24
- Terminated
- 2016-11-09
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.