Z-1828-2020Class II

Prismaflex System, Prismaflex Control Unit

Name: Z-1828-2020 Prismaflex System, Prismaflex Control Unit
Creator: Baxter Healthcare Corporation
Published: 2020-02-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-02-06 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex System, Prismaflex Control Unit on 2020-02-06. FDA classified it as Class II and gives the reason as "Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1828-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-06
Posted: 2020-04-30
Terminated: 2021-06-01
Recalling firm: Baxter Healthcare Corporation
Product: Prismaflex System, Prismaflex Control Unit
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
FDA root cause: Under Investigation by firm
Action: Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email.
Quantity in commerce: 4946 units
Distribution: Distribution in US, Puerto Rico
Product codes and lots: Product Code: 107493 GTIN 07332414073718

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1828-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1828-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30
Z-1829-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30
Z-1830-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30
Z-1831-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30
Z-1832-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30
Z-1833-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-30

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)