Baxter Healthcare Corporation: Medical Device Recall in 2019 - (Recall #: Z-1909-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Product Classification:

Class II

Date Initiated: May 31, 2019

Date Posted: July 10, 2019

Recall Number: Z-1909-2019

Event ID: 83015

Reason for Recall:

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

Status: Terminated

Product Quantity: 65403 units

Code Information:

UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301

Distribution Pattern:

US Nationwide Distribution and Internationally to: Canada and Bermuda.

Voluntary or Mandated:

Voluntary: Firm initiated