Z-1644-2014Class II

Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the...

Name: Z-1644-2014 Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the...
Creator: Gambro Renal Products, Incorporated
Published: 2014-04-16
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2014-04-16 / Terminated

FDA source

Gambro Renal Products, Incorporated began a recall of Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by... on 2014-04-16. FDA classified it as Class II and gives the reason as "The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1644-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-05-21
Terminated: 2015-12-08
Recalling firm: Gambro Renal Products
Product: Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. 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: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
FDA root cause: Storage
Action: The recall was initiated by an Urgent: Medical Device Recall letter delivered by UPS Overnight Delivery on April 16, 2014. The letter identified the affected product and reason for the recall. The firm is asking customers to remove and quarantine any remaining affected product from their inventory for collection and replacement. Customers are to also complete and return the Customer Reply Form to the Gambro Regulatory Affairs Department. Customers with affected product are to contact Gambro Customer Support or their Gambro representative to return the product. Questions should be directed to Customer Support at 1-800-651-2623.
Quantity in commerce: 2,461,824 units total
Distribution: Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Product codes and lots: Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1644-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1643-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21
Z-1644-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

Product code KDI

K060195Class IIGambro Polyflux Hd-C4 Capillary Dialyzer/filter for Single UseGambro Renal Products / cleared 2006-04-24

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)