The Recall Desk
HighFDA (Devices)·Z-1643-2014·Announced 2014-05-28

Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks

Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (hemodialysis) with reported internal blood leaks, which poses a risk of harm, but the source text does not explicitly report injuries, hospitalizations, or fatalities, nor is it classified as FDA Class I.

Plain-English summary

Gambro Renal Products, Incorporated is recalling Polyflux Revaclear capillary dialyzers, Model Number 110633. These medical devices are intended for the treatment of acute and chronic renal failure by hemodialysis.

The recall was initiated after the firm received several complaints regarding internal blood leaks involving various lot numbers produced in late 2013. A total of 2,461,824 units are affected by this recall.

The affected units were distributed worldwide, including the United States (including Puerto Rico), Bermuda, and Australia. Specific lot numbers are listed in the official recall documentation. Users should stop using the affected dialyzers and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; 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: C413124101
  • C413124301
  • C413124501
  • C413124601
  • C413124701
  • C413124801
  • C413124901
  • C413125001
  • C413125101
  • C413125201
  • C413125301
  • C413125401
  • C413125501
  • C413125601
  • C413125701
  • C413125801
  • C413125901
  • C413126001
  • C413126101
  • C413126201

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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