Recall Z-1278-2021— Baxter Healthcare Corporation

Name: FDA recall Z-1278-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-28

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-01-28, terminated 2024-06-13. It names one FDA 510(k) clearance: K110823. Product: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).. Reason: Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-01-28
Terminated: 2024-06-13
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110823 — PRISMAFLEXGambro Renal Products, Inc.·cleared 2011-06-17

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 - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

Reason for recall

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

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