Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1227-2026 — PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

U.S. FDA — Device Enforcement · United States · 2026-01-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1227-2026
Date of alert
2026-01-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
VANTIVE US HEALTHCARE LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07332414064556
Reported risk: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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