Z-0200-2007

Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A...

Name: Z-0200-2007 Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A...
Creator: Gambro Renal Products, Inc.
Published: 2006-05-12
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2006-05-12 / Terminated / root cause: manufacturing process

FDA source

Gambro Renal Products, Inc. began a recall of Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy on 2006-05-12. The reason FDA records is "Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient". 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-0200-2007
Status: Terminated
Initiated: 2006-05-12
Posted: 2006-11-21
Terminated: 2012-01-03
Recalling firm: Gambro Renal Products
Product: Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified by fax on 05/12/2006 and by letter on 05/16/2006. Until it was determined that their Phoenix system did not have an affected heat exchanger, users were instructed to disinfect the hydraulics flow path after each patient treatment. Gambro personnel will inspect each system and replace any affected heat exchangers.
Quantity in commerce: 613 machines (US), 170 machines (foreign)
Distribution: Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and Mexico.
Product codes and lots: Serial numbers: 11637 thru 12321.

Product code KDI

K001156Class IIPhoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood Tubing SetGambro Renal Products / cleared 2000-07-07

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)