Agency classClass IIOur severity:Severe FDA (Devices)·Z-1644-2014·Announced 2014-05-28

Gambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks

Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are rated as Severe (4). Internal blood leaks in a dialysis device represent a significant safety hazard.

Plain-English summary

Gambro Renal Products, Incorporated is recalling Polyflux Revaclear Max Capillary Dialyzers, Model Number 110634. These medical devices are intended for the treatment of acute and chronic renal failure by hemodialysis. The recall involves 2,461,824 units distributed in the United States, Puerto Rico, Bermuda, and Australia.

The recall was initiated after the firm received several complaints regarding internal blood leaks involving various lot numbers produced in late 2013. The affected lot numbers include C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.

Healthcare providers and patients should stop using these specific dialyzers and contact Gambro Renal Products for further instructions or replacement units.

The recalled product

Product: Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Manufacturer: Gambro Renal Products, Incorporated
Category: Medical Device — Dialysis Equipment
Hazard: internal-blood-leak
Affected units: 2,461,824

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot Numbers: C413204601
C413204801
C413204901
C413205101
C413205201
C413205301
C413205401
C413205501
C413205601
C413205701
C413205801
C413205901
C413206001
C414200101
C414200201
C414200301
C414200401
C414200701
C414200801
C414200901

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Gambro Renal Products, Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Gambro Renal Products, Incorporated

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Same hazard · internal blood leak