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Terminated

Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

FDA Recall Z-0489-2015 · Posted 2014-12-01

Recalling FirmGambro Renal Products Inc
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-11-05
Date Terminated2015-05-20
Product Quantity20 million dialyzers

Reason for Recall

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.

Firm Action

Recall letter was sent via UPS delivery next day to US customers on November 5th, 2014. Product that is returned will be quarantined at the distribution centers.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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