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

Polyflux Revaclear Max Dialyzer, Model Number 110634 — recall Z-0490-2015

U.S. FDA — Device Enforcement · United States · 2014-11-05 · Class II

As described by U.S. FDA — Device Enforcement: Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0490-2015
Date of alert
2014-11-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Gambro Renal Products Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Reported risk: Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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