CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report

Polyflux Revaclear, Capillary Dialyzer recalled by Gambro Renal Products

Gambro Renal Products is recalling Polyflux Revaclear, Capillary Dialyzer, distributed in Puerto Rico. The recall was initiated on 16 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.

Quantity recalled2,461,824 units total

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-1643-2014
FDA event ID: 67996
Recalling firm: Gambro Renal Products, Lakewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2014
FDA classified: 21 May 2014
Reported: 28 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Apr 2014	Recall initiated by company
21 May 2014	Classified by FDA	+35 days
28 May 2014	Published in enforcement report	+7 days

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

Reason for recall

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

Where it was distributed

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

Puerto Rico

Questions about this recall

Why was it recalled?

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Which lots are affected?

Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.

Where was it sold?

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

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.

Other products in this recall event

1 other product · FDA event 67996

This product is part of a recall event; the main page for the event is Polyflux Revaclear Max, Capillary Dialyzer recalled.

Reported	Class	Recall	Company	Reason	Where
28 May 2014	CLASS II	Polyflux Revaclear Max, Capillary Dialyzer recalled	Gambro Renal Products	Packaging Defects	PR

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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