FDA-Device2018-01-31Class II
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
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-0411-2018More Baxter Healthcare Corporation recalls
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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