Z-1409-2020 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

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