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Recall Observatory FDA recall evidence

Device product

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

Z-0411-2018

December 21, 2017

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 78835
Status
Terminated
Classification
Class II
Quantity
186 units
Official record key
device-enforcement:Z-0411-2018

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.