Z-1280-2018Class II

Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous...

Name: Z-1280-2018 Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous...
Creator: Baxter Healthcare Corporation
Published: 2017-02-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2017-02-15 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing... on 2017-02-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1280-2018
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Posted: 2018-03-30
Terminated: 2019-05-08
Recalling firm: Baxter Healthcare Corporation
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: On February 15, 2017, the firm sent an Urgent Device Correction notification and response form to affected customers via USPS first class mail in order to update software versions of the Prismaflex Control Units. The update was intended to prevent user errors related to the safe unloading of disposable sets. On May 30, 2017, the firm issued an updated notification letter notifying the same customer base of the issue with the programmed syringe sizes. The software update deployed to correct the issue with the safe unloading of disposable sets was also deployed to correct the issue with the programmed syringe sizes. All non-responding customers will be contacted via telephone. Prismaflex control units will be updated to a new software version. For further questions, please call (800) 422-9837.
Quantity in commerce: 3,440 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, Iceland, India, Iran, Israel, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine, Vietnam, Yemen, Argentina, Brazil, Chile, and Dominican Republic
Product codes and lots: Product code: 6023014700, 107493, 113081, 115269; Serial Number: All; Affected Software Versions: SW 4.1x, 5.10, 6.10, 7.xx, 8.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1280-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1280-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-03-30

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)