FDA Device recall Z-1644-2014
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634 by Gambro Renal Products, citing the firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1644-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-16 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Gambro Renal Products |
| Distribution | PR |
Product
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Reason
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Identifiers
| code_info | Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601…Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601. |
|---|
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-1644-2014%22
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