Baxter Healthcare Corporation: Medical Device Recall in 2020 - (Recall #: Z-1409-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Product Classification:

Class II

Date Initiated: November 15, 2019

Date Posted: March 11, 2020

Recall Number: Z-1409-2020

Event ID: 84339

Reason for Recall:

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

Status: Terminated

Product Quantity: 101976 devices

Code Information:

UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated