The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

Related recalls

Same manufacturer · Gambro Renal Products, Incorporated

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Same hazard · internal blood leak

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