⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

VANTIVE US HEALTHCARE LLC: PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Medical DevicesSource: FDA (device) · Date: 2026-02-11

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
VANTIVE US HEALTHCARE LLC
Product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason / hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-01-06
Code info
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Product quantity
230,596 units
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
98180
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