Z-1923-2018Class II

Prismaflex 5.10 US, Product Code 113081

Name: Z-1923-2018 Prismaflex 5.10 US, Product Code 113081
Creator: Baxter Healthcare Corporation
Published: 2018-04-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-04-24 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients... on 2018-04-24. FDA classified it as Class II and gives the reason as "Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1923-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-24
Posted: 2018-05-23
Terminated: 2021-06-22
Recalling firm: Baxter Healthcare Corporation
Product: Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " 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. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Baxter, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/24/2018 to its customers. The letter explained the reason for the recall and provided the following direction: "Operators may continue to safely use Prismaflex control units that have not exhibited the Voltage Out of Range malfunction alarm. A local Baxter service representative will contact your facility to determine the correction plan and schedule the firmware upgrade. Your facility will be receiving this firmware upgrade from Baxter at no charge. f you purchased this product directly from Baxter, complete the enclosed 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], even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. If you are 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." If you have any questions, call Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday or Email Baxter at: [email protected].
Quantity in commerce: 1256 units
Distribution: Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.
Product codes and lots: All Lots and Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1923-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1922-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23
Z-1923-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23
Z-1924-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23
Z-1925-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23
Z-1926-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23

Product code KDI

K110823Class IIPrismaflexGambro Renal Products, Inc. / cleared 2011-06-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)