Z-1409-2020 Class II Terminated
FDA device recall Z-1409-2020 was initiated by Baxter Healthcare Corporation on Nov 15, 2019 and is designated Class II. Reason for recall: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer. The recall status is terminated (terminated Nov 20, 2020). Affected quantity: 101976 devices.
Recall details
- Product Type
- Devices
- Report Date
- Mar 11, 2020
- Initiation Date
- Nov 15, 2019
- Termination Date
- Nov 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101976 devices
Product description
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Reason for recall
There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Distribution pattern
Nationwide
Code information
UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1409-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026