Infusion Pump: Cl II Alaris PC Unit

Company: CareFusion 303 Inc..
Date of Enforcement Report 3/30/2016
Class lI:

PRODUCT

Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092.
Recall Number Z-1239-2016

REASON
CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code (120.4630).

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 2/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
170 units

DISTRIBUTION
Nationwide

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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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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