Z-0278-2020Class II

Prismaflex Control Unit, software versions below 7.21

Name: Z-0278-2020 Prismaflex Control Unit, software versions below 7.21
Creator: Baxter Healthcare Corporation
Published: 2019-10-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2019-10-04 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex Control Unit, software versions below 7.21 on 2019-10-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0278-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-04
Posted: 2019-11-04
Recalling firm: Baxter Healthcare Corporation
Product: Prismaflex Control Unit, software versions below 7.21
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: software
FDA root cause: Software design
Action: Baxter Healthcare notified customers on about 10/04/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that Prismaflex Control Units with software versions 7.20 and below have the potential to produce communication errors. Instructions included that operators may continue to use the control units until the upgrade is performed, but if a communication error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operators manual. It must be reinforced that it is important to manually return the extracorporeal blood to the patient, and re-train users on this process, outlined on page 10:57 of the operators manual, if necessary. A local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade. If the affected devices was purchased from Baxter, complete the provided Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected]. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. For a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures. Questions regarding this recall can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
Quantity in commerce: 988 units
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.
Product codes and lots: Product Code: 114870; All Lot numbers; GTIN: 07332414115395. Device not distributed in the US.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0278-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0276-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-04
Z-0277-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-04
Z-0278-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-04
Z-0279-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-04
Z-0280-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-13	2019-11-04

Product code KDI

K072093Class IIPrismaflex System, Version 3.20Gambro / cleared 2008-02-01

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)