Z-2066-2020Class II

Prismaflex Control Unit

Name: Z-2066-2020 Prismaflex Control Unit
Creator: Baxter Healthcare Corporation
Published: 2020-04-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-04-07 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex Control Unit on 2020-04-07. FDA classified it as Class II and gives the reason as "Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2066-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Posted: 2020-05-21
Terminated: 2021-11-09
Recalling firm: Baxter Healthcare Corporation
Product: Prismaflex Control Unit
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
FDA root cause: Under Investigation by firm
Action: Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to [email protected], and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer Service at 787 866 70 27, between the hours of 7:00 am to 4:00 pm local time, Monday through Friday.
Quantity in commerce: 5 devices US territories
Distribution: Distribution only to Puerto Rico and Guam
Product codes and lots: Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2066-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code KDI

K131516Class IIPrismaflex System 7.10Gambro Renal Products, Inc. / cleared 2014-01-03

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)