Z-0695-2007

Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden

Name: Z-0695-2007 Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden
Creator: Gambro Renal Products, Inc.
Published: 2007-01-04
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2007-01-04 / Terminated / root cause: design

FDA source

Gambro Renal Products, Inc. began a recall of Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden on 2007-01-04. The reason FDA records is "Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0695-2007
Status: Terminated
Initiated: 2007-01-04
Posted: 2007-03-31
Terminated: 2012-01-03
Recalling firm: Gambro Renal Products
Product: Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant.
Quantity in commerce: 153 units (Domestic)
Distribution: Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI.
Product codes and lots: Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774.

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)