VANTIVE US HEALTHCARE LLC: Medical Device Recall in 2026 - (Recall #: Z-1227-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Product Classification:

Class II

Date Initiated: January 6, 2026

Date Posted: February 11, 2026

Recall Number: Z-1227-2026

Event ID: 98180

Reason for Recall:

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Status: Ongoing

Product Quantity: 230,596 units

Code Information:

UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated