11
Apr
2018

Prismaflex Control Unit Cl II

0

Company:Baxter Healthcare Corporation
Date of Enforcement Report 4/11/2018
Class lI:

PRODUCT

Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
Recall Number Z-1280-2018

REASON
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, IL on 2/15/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,440 units

DISTRIBUTION
Nationwide and Internationally

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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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