Z-1409-2020 Class II Terminated
FDA device recall Z-1409-2020 was initiated by Baxter Healthcare Corporation on November 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 November 20, 2020). Affected quantity: 101976 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- November 15, 2019
- Termination Date
- November 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