Recall Z-1280-2018— Baxter Healthcare Corporation

Name: FDA recall Z-1280-2018
Creator: U.S. Food and Drug Administration
Published: 2017-02-15

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2017-02-15, terminated 2019-05-08. It names one FDA 510(k) clearance: K110823. 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. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.. 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: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Terminated: 2019-05-08
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. 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. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.

Reason for recall

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.

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