FDA Device recall Z-1409-2020
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
- FDA Device
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L by Baxter Healthcare, citing there is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1409-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-15 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Reason
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Identifiers
| code_info | UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2020%22
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