Recall Z-1227-2026— VANTIVE US HEALTHCARE LLC

Name: FDA recall Z-1227-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-06

Class II · Ongoing

Class II FDA medical device recall by VANTIVE US HEALTHCARE LLC, initiated 2026-01-06. It names one FDA 510(k) clearance: K041005. Product: PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System. Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit..

Recalling firm: VANTIVE US HEALTHCARE LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-01-06
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K041005 — GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSGambro Renal Products·cleared 2004-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PRIMSAFLEX M100 SET, Product Code 106697; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.