07
Oct
2014

Cl II Baxter SPECTRUM Pump

,
0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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