Recall Z-0278-2020— Baxter Healthcare Corporation

Name: FDA recall Z-0278-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-04

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-10-04. It names one FDA 510(k) clearance: K072093. Product: Prismaflex Control Unit, software versions below 7.21. 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: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2019-10-04
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K072093 — PRISMAFLEX SYSTEM, VERSION 3.20Gambro·cleared 2008-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Prismaflex Control Unit, software versions below 7.21

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.