Z-2437-2025Class II

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

Name: Z-2437-2025 PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Creator: Vantive US Healthcare Llc
Published: 2025-07-28
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-07-28 / Open, Classified

FDA source

VANTIVE US HEALTHCARE LLC began a recall of PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 on 2025-07-28. FDA classified it as Class II and gives the reason as "Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2437-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-28
Posted: 2025-08-26
Recalling firm: Baxter Healthcare Corporation
Product: PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
FDA root cause: Under Investigation by firm
Action: Vantive issued an Urgent Medical Device Correction notice to it consignees on 0728/2025 via USPS first class mail. The notice explained the issues with the devices, hazard involved, and requested the following: Actions to be Taken by Customers 1. Operators may continue to safely use the PrisMax Systems and TherMax Blood Warmer Units per the associated Operator s Manuals and on-screen instructions. If further assistance is required, please contact your local Vantive account representative. Please ensure that all operators of these devices are made aware of this Urgent Medical Device Correction notification. Vantive recommends that a copy of this notification is posted within the appropriate location of your facility. 2. As corrections become available, a local Vantive representative will contact your facility to determine the correction plan and schedule the associated correction(s) for impacted devices. 3. If you received this communication directly from Vantive, complete the enclosed Vantive Customer Reply Form and return it to Vantive by scanning and e-mailing it to [email protected]. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive an email and/or phone call from Vantive to confirm your receipt of this notification. 4. If you purchased this product from a distributor, please note that responding using the Vantive Customer Reply Form is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your
Quantity in commerce: 4772 units
Distribution: Worldwide
Product codes and lots: UDI 00085412639499, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2437-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2437-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2438-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26
Z-2439-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26

Product code KDI

K190910Class IIPrisMax System Version 2Baxter Healthcare Corp / cleared 2019-07-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)