Z-0489-2015Class II

Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers...

Name: Z-0489-2015 Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers...
Creator: Gambro Renal Products Inc
Published: 2014-11-05
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2014-11-05 / Terminated / root cause: manufacturing process

FDA source

Gambro Renal Products Inc began a recall of Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment... on 2014-11-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0489-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-05
Posted: 2014-12-01
Terminated: 2015-05-20
Recalling firm: Gambro Renal Products
Product: 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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 20 million dialyzers
Distribution: Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Product codes and lots: Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0489-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0489-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-01
Z-0490-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-01

Product code KDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)