Z-1861-2008

Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the...

Name: Z-1861-2008 Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the...
Creator: Gambro Renal Products, Inc.
Published: 2008-05-02
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2008-05-02 / Terminated / root cause: manufacturing process

FDA source

Gambro Renal Products, Inc. began a recall of Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems on 2008-05-02. The reason FDA records is "Dialysis tubing sets may have occlusions restricting blood flow". 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-1861-2008
Status: Terminated
Initiated: 2008-05-02
Posted: 2008-09-26
Terminated: 2012-05-22
Recalling firm: Gambro Renal Products
Product: Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Dialysis tubing sets may have occlusions restricting blood flow.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were sent an "Urgent Product Safety Notice" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an "Urgent Product Recall" letter was sent to all customers requesting the return of all remaining affected blood sets.
Distribution: Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
Product codes and lots: Serial numbers: 0XP15XXXX (all lots)

Product code FJK

K070414Class IIGambro Cartridge Blood SetsGambro Renal Products / cleared 2007-10-12

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)