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.
Product Quantity:
101976 devices
Recall Number:
Z-1409-2020
Code Information:
UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401
Classification:
Class II
Event ID:
84339
Voluntary / Mandated:
Voluntary: Firm initiated
Product Type:
Devices
Initial Firm Notification of Consignee or Public:
Letter
Status:
Ongoing
Distribution Pattern:
Nationwide
Recalling Firm:
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield, IL 60015-4625
United States
Recall Initiation Date:
11/15/2019
Center Classification Date:
2/28/2020