Baxter Healthcare Corporation: Medical Device Recall in 2018 - (Recall #: Z-0411-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541

Product Classification:

Class II

Date Initiated: December 21, 2017

Date Posted: January 31, 2018

Recall Number: Z-0411-2018

Event ID: 78835

Reason for Recall:

Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.

Status: Terminated

Product Quantity: 186 units

Code Information:

UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767

Distribution Pattern:

US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated