Z-1229-2026Class II

PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate...

Name: Z-1229-2026 PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate...
Creator: Vantive US Healthcare Llc
Published: 2026-01-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-01-06 / Open, Classified / root cause: design

FDA source

VANTIVE US HEALTHCARE LLC began a recall of PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System on 2026-01-06. FDA classified it as Class II and gives the reason as "There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1229-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-06
Posted: 2026-02-02
Recalling firm: Baxter Healthcare Corporation
Product: PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Root cause tag: design
FDA root cause: Component design/selection
Action: Vantive issued an Urgent Medical Device Correction notice to its consignees on 01/06/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: 1. You may continue to perform therapy using the Prismaflex sets listed above. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. 2. Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright position, please consider the following: . Ensure there are no kinks in the tubing and that the deaeration chamber remains visible. . If the Prismaflex Control Unit issues an Air in Blood alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present. 1. If no dislodgement, please follow the operator s manual instructions for Air in Blood alarm. 2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator s manual to stop the therapy and replace the set. 3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator s manual to proceed with treatment. Facilities who further distributed the products were directed to notify those departments or facilities. Dealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) who further distributed the products were directed to notify their customers. For general questions regarding this communication, please contact Vantive Customer Care at 833-542-CRRT (2778). Vantive Customer Care is available 24 hours a day, seven days a week.
Quantity in commerce: 93,576 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 07332414069254, All lots including and manufactured after 24G0034CA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1229-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1224-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1225-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1226-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1227-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1228-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1229-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1230-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1231-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02

Product code KDI

K042938Class IIGambro Prismaflex Hf1000 and Hf1400 SetsGambro Renal Products / cleared 2005-01-06

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)