CLASS II Device recall · Reported 10 Dec 2014 · FDA Enforcement Report
Polyflux Revaclear Dialyzer recalled by Gambro Renal Products
Gambro Renal Products is recalling Polyflux Revaclear Dialyzer, distributed nationwide in the US. The recall was initiated on 5 Nov 2014 and the FDA has classified it as Class II.
Check your package
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-0489-2015
- FDA event ID
- 69786
- Recalling firm
- Gambro Renal Products, Opelika, AL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2014
- FDA classified
- 1 Dec 2014
- Reported
- 10 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2014 | Recall initiated by company | |
| 1 Dec 2014 | Classified by FDA | +26 days |
| 10 Dec 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Where it was distributed
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
Questions about this recall
Is Polyflux Revaclear Dialyzer recalled?
Yes. Gambro Renal Products recalled Polyflux Revaclear Dialyzer on 5 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0489-2015.
Why was it recalled?
Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
Which lots are affected?
Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
Where was it sold?
Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
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 21 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 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Polyflux Revaclear Max Dialyzer recalled by Gambro Renal Products | Gambro Renal Products | Sterility | Nationwide |
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| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |