Baxter Healthcare Corp.: Medical Device Recall in 2016 - (Recall #: Z-0370-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.

Product Classification:

Class II

Date Initiated: October 12, 2016

Date Posted: November 16, 2016

Recall Number: Z-0370-2017

Event ID: 75414

Reason for Recall:

Potential presence of particulate matter on the blood side of the dialyzer

Status: Terminated

Product Quantity: 22,656 units

Code Information:

C416201601

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated