Polyflux Revaclear Dialyzer — Class II medical device recall Z-0489-2015
Terminated recall by Gambro Renal Products Inc, reported 2014-12-10, distributed nationwide. Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to
| Recall number | Z-0489-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gambro Renal Products Inc, Opelika, AL, United States |
| Recall initiated | 2014-11-05 |
| Classified | 2014-12-01 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 20 million |
| Reason classes | sterility |
| Lot numbers | C412120501, C412127501, C413100101, C413129601, C414100101, C414119301, C414120001 |
| Model numbers | 110633 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0489-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.