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

Recall Z-1644-2014 — Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

U.S. FDA — Device Enforcement · United States · 2014-04-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1644-2014
Date of alert
2014-04-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Gambro Renal Products, Incorporated
Product category
device
Product type
Devices
Reported risk: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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