Z-0411-2018 Class II Terminated
FDA device recall Z-0411-2018 was initiated by Baxter Healthcare Corporation on Dec 21, 2017 and is designated Class II. 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… The recall status is terminated (terminated Aug 4, 2020). Affected quantity: 186 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 31, 2018
- Initiation Date
- Dec 21, 2017
- Termination Date
- Aug 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186 units
Product description
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 pattern
US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
Code information
UDI: 37332414107728; Lot Numbers: 0000022597, 0000022648, 0000022663, 0000022671, 0000022721, 0000022767
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0411-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026