Aug

2015

Model No. 8110, Class I Alaris Syringe Pump

Company: CareFusion 303, Inc.
Date of Enforcement Report 8/26/2015
Class l:

PRODUCT

Alaris Syringe Pump, Model No. 8110. Delivers fluids.
Recall Number Z-2362-2015

REASON
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached..

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego CA on 7/21/2015.Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7418 units

DISTRIBUTION
Nationwide and Internationally

FDA District: Los Angeles

___________________________________

About the author

Amy Sellers

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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Model No. 8110, Class I Alaris Syringe Pump

Amy Sellers

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