FDA-Device2014-10-08Class II

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

Baxter Healthcare Corp.
Hazard

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.

Sold states
Worldwide Distribution -- USA and Canada.
Affected count
USA: 56 units, Canada: 2 units
Manufactured in
25212 W. Illinois Route 120, N/A, Round Lake, IL, United States
Products
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2014

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