Jan

2017

Alaris Syringe Pump Module Class I

Company: Carefusion
Date of Enforcement Report 1/25/2017
Class I:

PRODUCT

Product Description: Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits
Recall number Z-0950-2017

REASON
CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the health care provider to clear the alarm to restart the infusion. Interruption of infusion could lead to serious adverse health consequences or death.

RECALLING FIRM/MANUFACTURER
CareFusion San Diego, CA12/2/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
382,635 units

DISTRIBUTION
Nationwide

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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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Alaris Syringe Pump Module Class I

Amy Sellers

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