Z-1455-2014Class II

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510)...

Name: Z-1455-2014 Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510)...
Creator: Gambro Renal Products, Incorporated
Published: 2013-12-09
License: https://open.fda.gov/license/

Gambro Renal Products / initiated 2013-12-09 / Terminated / root cause: manufacturing process

FDA source

Gambro Renal Products, Incorporated began a recall of Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) -... on 2013-12-09. FDA classified it as Class II and gives the reason as "Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets". 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-1455-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Posted: 2014-04-11
Terminated: 2015-12-22
Recalling firm: Gambro Renal Products
Product: Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.
Product code: FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Reason for recall: Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification.
Quantity in commerce: 306,525 sets (20435 boxes of 15 sets)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
Product codes and lots: Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1455-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1455-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-11

Product code FJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)