11
Aug
2010

Cl ll Medfusion Syringe Infusion Pumps

,
0

Company: Smiths Medical ASD, Inc.
Date of Enforcement Report 8/11//2010
Class ll:

PRODUCT
Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. Recall # Z-2121-2010

REASON
Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient injury or death related to this issue.

RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated June 11, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4,816 units

DISTRIBUTION
Nationwide and Internationally

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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