WhichRecall
Class IIReported 2026-02-11

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

Recalled by VANTIVE US HEALTHCARE LLC

Reason for Recall

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

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Recall Number
Z-1227-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-06
Reported
2026-02-11
Distribution
US Nationwide distribution.
Code Info
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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