Cl II Baxter SPECTRUM Pump

Company: Baxter Healthcare Corp..
Date of Enforcement Report:10/7/2014
Class lI:

PRODUCT

SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids. Recall Number Z-2738-2014

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/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL on 9/3/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
USA: 56 units, Canada: 2 units

DISTRIBUTION
USA and Canada

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