Polyflux Revaclear — Class II medical device recall Z-1643-2014
Terminated recall by Gambro Renal Products, Incorporated, reported 2014-05-28, distributed in PR. The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2
| Recall number | Z-1643-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gambro Renal Products, Incorporated, Lakewood, CO, United States |
| Recall initiated | 2014-04-16 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-12-08 |
| Distributed | PR |
| Countries outside the US | AU, BM |
| Quantity | 2,461,824 units |
| Reason classes | packaging |
| Lot numbers | C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201 and 24 more |
| Model numbers | 110633 |
Product
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Reason for recall
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
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-1643-2014. 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.