FDA Device recall Z-0370-2017
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single us…
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single us… by Baxter Healthcare, citing potential presence of particulate matter on the blood side of the dialyzer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0370-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-12 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Reason
Potential presence of particulate matter on the blood side of the dialyzer
Identifiers
| code_info | C416201601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0370-2017%22
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