Recall Z-2738-2014— Baxter Healthcare Corp.

Name: FDA recall Z-2738-2014
Creator: U.S. Food and Drug Administration
Published: 2014-09-03

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-09-03, terminated 2017-03-16. It names one FDA 510(k) clearance: K042121. Product: SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.. Reason: One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-09-03
Terminated: 2017-03-16
Firm location: Round Lake, 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

SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

Reason for recall

One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.

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