Recall Z-0197-2014— Baxter Healthcare Corp.

Name: FDA recall Z-0197-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-10

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-06-10, terminated 2017-04-20. It names one FDA 510(k) clearance: K042121. Product: SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.. Reason: Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Terminated: 2017-04-20
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K042121 — SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARYSigma Intl.·cleared 2004-08-26

K-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. Intended to be used for the controlled administration of intravenous fluids.

Reason for recall

Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

Data sourced from openFDA. This site is unofficial and independent of the FDA.