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

Recall Z-1102-2014 — Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.

U.S. FDA — Device Enforcement · United States · 2014-02-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1102-2014
Date of alert
2014-02-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Holdings, Inc.
Product category
device
Product type
Devices
Reported risk: Dialysate Port Leak During Priming of the Dialyzers
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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