Recall – Continuous Renal Replacement Therapy (CRRT) system error results in interruption of therapy

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 11/13/2019
Class II

PRODUCT

Prismaflex Control Unit, software versions below 7.21

  • Recall Number: Z-0276-2020

REASON

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

RECALLING FIRM/MANUFACTURER

Baxter Healthcare Corporation on 10/4/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2,760 units

DISTRIBUTION

Nationwide and International

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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