Baxter Healthcare Corporation: Medical Device Recall in 2022 - (Recall #: Z-1145-2022)

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:

3,65 m Extension Set with Luer-lock Connector

Product Classification:

Class II

Date Initiated: April 21, 2022

Date Posted: June 8, 2022

Recall Number: Z-1145-2022

Event ID: 90032

Reason for Recall:

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Status: Ongoing

Product Quantity: 60 units

Code Information:

Product code: R5C4480F; UDI: 00085412577142; Lot Number: H19G12025 (exp. date: 07/12/2024)

Distribution Pattern:

US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.

Voluntary or Mandated:

Voluntary: Firm initiated