Baxter Healthcare Corporation: Medical Device Recall in 2021 - (Recall #: Z-1118-2021)

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 Prime Line, 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: December 30, 2020

Date Posted: February 24, 2021

Recall Number: Z-1118-2021

Event ID: 87150

Reason for Recall:

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Status: Ongoing

Product Quantity: 7437480 units

Code Information:

UDI 07332414007836, All lots within expiry

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated