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

Recall Z-0658-2019 — Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

U.S. FDA — Device Enforcement · United States · 2018-11-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0658-2019
Date of alert
2018-11-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Reported risk: Potential for external blood leaks from the dialyzer header
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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