Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-1653-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Product Classification:

Class I

Date Initiated: August 9, 2022

Date Posted: September 21, 2022

Recall Number: Z-1653-2022

Event ID: 90730

Reason for Recall:

Firm noted an increase in customer reports of leaks.

Status: Terminated

Product Quantity: 511,728 units

Code Information:

UDI/DI 00085412656649, All lots within expiry

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated