FDA-Device2018-01-31Class II
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Baxter Healthcare Corporation
Hazard
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.
Sold states
US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
Affected count
186 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2018Don't want to check this manually?
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