CLASS II Device recall · Reported 23 Apr 2014 · FDA Enforcement Report

Gambro Cartridge Blood Set, blood transport system for hemodialysis recalled

Gambro Renal Products is recalling Gambro Cartridge Blood Set, blood transport system for hemodialysis, distributed nationwide in the US. The recall was initiated on 9 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

Quantity recalled306,525 sets (20435 boxes of 15 sets)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1455-2014
FDA event ID: 67797
Recalling firm: Gambro Renal Products, Lakewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 9 Dec 2013
FDA classified: 11 Apr 2014
Reported: 23 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Dec 2013	Recall initiated by company
11 Apr 2014	Classified by FDA	+123 days
23 Apr 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.

Nationwide

Questions about this recall

Why was it recalled?

Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Which lots are affected?

Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

Where was it sold?

Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Gambro Renal Products

All 20

Reported	Class	Recall	Company	Reason	Where
10 Dec 2014Device	CLASS II	Polyflux Revaclear Dialyzer recalled by Gambro Renal Products	Gambro Renal Products	Sterility	Nationwide
10 Dec 2014Device	CLASS II	Polyflux Revaclear Max Dialyzer recalled by Gambro Renal Products	Gambro Renal Products	Sterility	Nationwide
20 Aug 2014Device	CLASS II	Prismaflex HF recalled by Gambro Renal Products	Gambro Renal Products	Packaging Defects	CO
20 Aug 2014Device	CLASS II	Prisma M100 set recalled by Gambro Renal Products	Gambro Renal Products	Packaging Defects	CO
20 Aug 2014Device	CLASS II	Prismaflex M60 set recalled by Gambro Renal Products	Gambro Renal Products	Packaging Defects	CO

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