FDA recall Z-0411-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-12-21

Report date

2018-01-31

Termination date

2020-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2018