FDA Device recall Z-0489-2015
Polyflux Revaclear Dialyzer, Model Number 110633
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Polyflux Revaclear Dialyzer, Model Number 110633 by Gambro Renal Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-05 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gambro Renal Products |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2015%22
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