Baxter Healthcare Corporation: Medical Device Recall in 2021 - (Recall #: Z-1684-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Product Classification:

Class II

Date Initiated: April 14, 2021

Date Posted: June 2, 2021

Recall Number: Z-1684-2021

Event ID: 87739

Reason for Recall:

There is a potential leak between the venous patient connector and patient's hemodialysis access.

Status: Terminated

Product Quantity: 17,487 units

Code Information:

Product Code: 101025; Lot 1000276191, UDI: 37332414007837

Distribution Pattern:

Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.

Voluntary or Mandated:

Voluntary: Firm initiated