Z-0032-2007

Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy

Name: Z-0032-2007 Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy
Creator: Gambro Renal Products, Inc.
Published: 2006-05-16
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2006-05-16 / Terminated / root cause: software

FDA source

Gambro Renal Products, Inc. began a recall of Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy on 2006-05-16. The reason FDA records is "A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0032-2007
Status: Terminated
Initiated: 2006-05-16
Posted: 2006-10-12
Terminated: 2012-01-03
Recalling firm: Gambro Renal Products
Product: Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified by letter on 05/16/2006.
Quantity in commerce: 153 units (US)
Distribution: Nationwide.
Product codes and lots: Serial numbers: PA0101 to PA0681.

Product code KDI

K041005Class IIGambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products / cleared 2004-10-07

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)