Recall Z-1484-2014— Baxter Healthcare Corp.

Name: FDA recall Z-1484-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-07

Class I · Terminated

Class I FDA medical device recall by Baxter Healthcare Corp., initiated 2014-02-07, terminated 2017-05-25. It names one FDA 510(k) clearance: K042121. Product: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for 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 has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences..

Recalling firm: Baxter Healthcare Corp.
Classification: Class I
Status: Terminated
Initiated: 2014-02-07
Terminated: 2017-05-25
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 Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for 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 has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.

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